Surgical Site Infections

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

Schwartz_Suzanne_MD_web.jpg

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

Schwartz_Suzanne_MD_web.jpg

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

The US Food and Drug Administration has expanded its guidance on medical device sterilization to include vaporized hydrogen peroxide, according to an agency press release issued on January 8.

The update is intended to promote wider use of vaporized hydrogen peroxide (VHP) as a viable alternative to ethylene oxide (EtO). The FDA guidance on sterile devices has been revised to include VHP.

The acceptance of VHP as an Established Category A method of sterilization is another step toward the FDA’s larger goal of reducing EtO, according to the release.

Sterilization is essential for certain medical devices, but the use of EtO, currently the most common method, involves the release of emissions that are potentially harmful to health, and the FDA seeks to identify safe and effective alternatives to reduce risk to the environment and communities where device sterilization occurs. Current Established Category A sterilization methods include moist heat, dry heat, EtO, and radiation. 

Schwartz_Suzanne_MD_web.jpg

“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, MD, director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in the press release. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health,” she said.

The FDA has supported the development of EtO alternatives since 2019, and remains committed to reducing EtO emissions and also to avoiding potential device shortages, according to the release.

“Ethylene oxide is highly flammable and carcinogenic and poses exposure-related safety concerns for reprocessing staff, as well as environmental risks,” said Venkataraman R. Muthusamy, MD, AGAF, of the University of California, Los Angeles, in an interview. “These risks have led some states or regions to ban or limit its use, but despite these risks, it is currently the most commonly used sterilization technique for medical devices in the United States,” he said. Therefore, coming up with alternatives has been a high priority for the FDA, he added.

VHP has several advantages over EtO, Dr. Muthusamy said. VHP breaks down safely into water and oxygen, with low residual levels after exposure, and has no known oxidation or discoloration effects. In addition, VHP has a low temperature, and should theoretically be safe to use with endoscopes, although data are lacking, he said.

Dr. Muthusamy said that he was not yet too familiar with VHP as a technique, in part because most accessories in GI are single-use.

Primary issues to expanding the use of vaporized hydrogen peroxide as a sterilizing agent in GI clinical practice include availability and the cost of acquiring the devices needed, Dr. Muthusamy told GI & Hepatology News. “Also, the comparative efficacy of this technique in sterilizing GI endoscopes to ethylene oxide and the impact of VHP on scope durability and performance will need to be assessed, and the impact of VHP on the health and safety of reprocessing staff will need to be assessed and monitored,” he said.

There is an interest in the GI community in “green” endoscopy and reducing waste, Dr. Muthusamy said. If an inexpensive, safe, and cost-effective option for sterilization of other devices beyond endoscopes exists, “perhaps we could reduce our use of some disposables as well,” he said.

Dr. Muthusamy had no financial conflicts to disclose. 

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

155986_map_web.jpg

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

155986_map_web.jpg

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

More than HIV, more than malaria. The death toll worldwide from bacterial antimicrobial resistance (AMR) in 2019 exceeded 1.2 million people, according to a new study.

In terms of preventable deaths, 1.27 million people could have been saved if drug-resistant infections were replaced with infections susceptible to current antibiotics. Furthermore, 4.95 million fewer people would have died if drug-resistant infections were replaced by no infections, researchers estimated.

Although the COVID-19 pandemic took some focus off the AMR burden worldwide over the past 2 years, the urgency to address risk to public health did not ebb. In fact, based on the findings, the researchers noted that AMR is now a leading cause of death worldwide.

“If left unchecked, the spread of AMR could make many bacterial pathogens much more lethal in the future than they are today,” the researchers noted in the study, published online Jan. 20, 2022, in The Lancet.

“These findings are a warning signal that antibiotic resistance is placing pressure on health care systems and leading to significant health loss,” study author Kevin Ikuta, MD, MPH, told this news organization.

“We need to continue to adhere to and support infection prevention and control programs, be thoughtful about our antibiotic use, and advocate for increased funding to vaccine discovery and the antibiotic development pipeline,” added Dr. Ikuta, health sciences assistant clinical professor of medicine at the University of California, Los Angeles.

Although many investigators have studied AMR, this study is the largest in scope, covering 204 countries and territories and incorporating data on a comprehensive range of pathogens and pathogen-drug combinations.

Dr. Ikuta, lead author Christopher J.L. Murray, DPhil, and colleagues estimated the global burden of AMR using the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019. They specifically looked at rates of death directly attributed to and separately those associated with resistance.
 

Regional differences

Broken down by 21 regions, Australasia had 6.5 deaths per 100,000 people attributable to AMR, the lowest rate reported. This region also had 28 deaths per 100,000 associated with AMR.

Researchers found the highest rates in western sub-Saharan Africa. Deaths attributable to AMR were 27.3 per 100,000 and associated death rate was 114.8 per 100,000.

Lower- and middle-income regions had the highest AMR death rates, although resistance remains a high-priority issue for high-income countries as well.

“It’s important to take a global perspective on resistant infections because we can learn about regions and countries that are experiencing the greatest burden, information that was previously unknown,” Dr. Ikuta said. “With these estimates policy makers can prioritize regions that are hotspots and would most benefit from additional interventions.”

Furthermore, the study emphasized the global nature of AMR. “We’ve seen over the last 2 years with COVID-19 that this sort of problem doesn’t respect country borders, and high rates of resistance in one location can spread across a region or spread globally pretty quickly,” Dr. Ikuta said.
 

Leading resistant infections

Lower respiratory and thorax infections, bloodstream infections, and intra-abdominal infections together accounted for almost 79% of such deaths linked to AMR.

The six leading pathogens are likely household names among infectious disease specialists. The researchers found Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Streptococcus pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa, each responsible for more than 250,000 AMR-associated deaths.

The study also revealed that resistance to several first-line antibiotic agents often used empirically to treat infections accounted for more than 70% of the AMR-attributable deaths. These included fluoroquinolones and beta-lactam antibiotics such as carbapenems, cephalosporins, and penicillins.

155986_map_web.jpg

Potential solutions offered

Dr. Murray and colleagues outlined five strategies to address the challenge of bacterial AMR:

• Infection prevention and control remain paramount in minimizing infections in general and AMR infections in particular.
• More vaccines are needed to reduce the need for antibiotics. “Vaccines are available for only one of the six leading pathogens (S. pneumoniae), although new vaccine programs are underway for S. aureus, E. coli, and others,” the researchers wrote.
• Reduce antibiotic use unrelated to treatment of human disease.
• Avoid using antibiotics for viral infections and other unnecessary indications.
• Invest in new antibiotic development and ensure access to second-line agents in areas without widespread access.

“Identifying strategies that can work to reduce the burden of bacterial AMR – either across a wide range of settings or those that are specifically tailored to the resources available and leading pathogen-drug combinations in a particular setting – is an urgent priority,” the researchers noted.
 

Admirable AMR research

The results of the study are “startling, but not surprising,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C.

The authors did a “nice job” of addressing both deaths attributable and associated with AMR, Dr. Fowler added. “Those two categories unlock applications, not just in terms of how you interpret it but also what you do about it.”

The deaths attributable to AMR show that there is more work to be done regarding infection control and prevention, Dr. Fowler said, including in areas of the world like lower- and middle-income countries where infection resistance is most pronounced.

The deaths associated with AMR can be more challenging to calculate – people with infections can die for multiple reasons. However, Dr. Fowler applauded the researchers for doing “as good a job as you can” in estimating the extent of associated mortality.
 

‘The overlooked pandemic of antimicrobial resistance’

In an accompanying editorial in The Lancet, Ramanan Laxminarayan, PhD, MPH, wrote: “As COVID-19 rages on, the pandemic of antimicrobial resistance continues in the shadows. The toll taken by AMR on patients and their families is largely invisible but is reflected in prolonged bacterial infections that extend hospital stays and cause needless deaths.”

Dr. Laxminarayan pointed out an irony with AMR in different regions. Some of the AMR burden in sub-Saharan Africa is “probably due to inadequate access to antibiotics and high infection levels, albeit at low levels of resistance, whereas in south Asia and Latin America, it is because of high resistance even with good access to antibiotics.”

More funding to address AMR is needed, Dr. Laxminarayan noted. “Even the lower end of 911,000 deaths estimated by Murray and colleagues is higher than the number of deaths from HIV, which attracts close to U.S. $50 billion each year. However, global spending on addressing AMR is probably much lower than that.” Dr. Laxminarayan is an economist and epidemiologist affiliated with the Center for Disease Dynamics, Economics & Policy in Washington, D.C., and the Global Antibiotic Research and Development Partnership in Geneva.
 

An overlap with COVID-19

The Lancet report is likely “to bring more attention to AMR, especially since so many people have been distracted by COVID, and rightly so,” Dr. Fowler predicted. “The world has had its hands full with COVID.”

The two infections interact in direct ways, Dr. Fowler added. For example, some people hospitalized for COVID-19 for an extended time could develop progressively drug-resistant bacteria – leading to a superinfection.

The overlap could be illustrated by a Venn diagram, he said. A yellow circle could illustrate people with COVID-19 who are asymptomatic or who remain outpatients. Next to that would be a blue circle showing people who develop AMR infections. Where the two circles overlap would be green for those hospitalized who – because of receiving steroids, being on a ventilator, or getting a central line – develop a superinfection.
 

Official guidance continues

The study comes in the context of recent guidance and federal action on AMR. For example, the Infectious Diseases Society of America released new guidelines for AMR in November 2021 as part of ongoing advice on prevention and treatment of this “ongoing crisis.”

This most recent IDSA guidance addresses three pathogens in particular: AmpC beta-lactamase–producing Enterobacterales, carbapenem-resistant A. baumannii, and Stenotrophomonas maltophilia.

Also in November, the World Health Organization released an updated fact sheet on antimicrobial resistance. The WHO declared AMR one of the world’s top 10 global public health threats. The agency emphasized that misuse and overuse of antimicrobials are the main drivers in the development of drug-resistant pathogens. The WHO also pointed out that lack of clean water and sanitation in many areas of the world contribute to spread of microbes, including those resistant to current treatment options.

In September 2021, the Biden administration acknowledged the threat of AMR with allocation of more than $2 billion of the American Rescue Plan money for prevention and treatment of these infections.

Asked if there are any reasons for hope or optimism at this point, Dr. Ikuta said: “Definitely. We know what needs to be done to combat the spread of resistance. COVID-19 has demonstrated the importance of global commitment to infection control measures, such as hand washing and surveillance, and rapid investments in treatments, which can all be applied to antimicrobial resistance.”

The Bill & Melinda Gates Foundation, the Wellcome Trust, and the U.K. Department of Health and Social Care using U.K. aid funding managed by the Fleming Fund and other organizations provided funding for the study. Dr. Ikuta and Dr. Laxminarayan have disclosed no relevant financial relationships. Dr. Fowler reported receiving grants or honoraria, as well as serving as a consultant, for numerous sources. He also reported a patent pending in sepsis diagnostics and serving as chair of the V710 Scientific Advisory Committee (Merck).

A version of this article first appeared on Medscape.com.

Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.

In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.

The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.

The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.

“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.

CPN Biosciences funded the study. No authors had relevant financial disclosures.

lfranki@mdedge.com

SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73

Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.

In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.

The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.

The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.

“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.

CPN Biosciences funded the study. No authors had relevant financial disclosures.

lfranki@mdedge.com

SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73

Collagen powder may be noninferior to primary closure for healing punch biopsy–induced wounds and possibly leads to improved early cosmetic outcomes and accelerated wound maturation, according to Azam Qureshi of the University of Maryland, Baltimore, and associates.

In a small pilot study published in Journal of Drugs in Dermatology, eight volunteers (mean age, 37 years) received a 4-mm punch biopsy on each thigh. One wound was managed with primary closure, the other with daily application of collagen powder. The wounds were biopsied at 4 weeks for histopathologic analysis, and the study subjects rated pain, itch, and treatment preferences at 1, 2, 4, 6, and 12 weeks.

The size of wounds treated with collagen was reduced by 28.95% at 1 week, 55.76% at 2 weeks, and 95.94% at 4 weeks; six of the eight collagen-treated wounds were completely healed at 4 weeks. Wound size was reduced by 75.71% 1 week after the second biopsy, much faster than the initial healing. In addition to collagen, one patient required hyfrecation for hemostasis, which did not affect results; three of the eight subjects rated the collagen treatment as “annoying,” but no one rated it as “difficult,” and patients generally regarded collagen treatment as more time consuming.

The histopathologic analysis showed epidermal reepithelialization in collagen-treated wounds and wounds managed with primary closure, with more organized granulation tissue in the collagen-treated wounds. Similar pain and itch ratings were reported between wound types, and both patients and blinded dermatologists observing the study preferred the appearance of collagen-treated wounds.

“Future research elucidating the optimal duration of collagen therapy is needed, as less than 4 weeks may be sufficient. Shortened treatment courses would decrease the cost and effort required by patients. Future studies should also investigate the efficacy of collagen powder in healing larger wounds and in comparison to healing by secondary intention,” the investigators wrote.

CPN Biosciences funded the study. No authors had relevant financial disclosures.

lfranki@mdedge.com

SOURCE: Qureshi A et al. J Drug Dermatol. 2019;18(7):667-73

BALTIMORE – While rates of surgical site infections after bariatric surgery have been reported in the low single digits, SSIs have continued to be a persistent complication.

139552_Dang_Jerry_web.jpg

At the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons, researchers reported on two strategies to reduce SSI in bariatric surgery: a predictive tool that identifies risk factors for wound infection, allowing surgeons to employ protective measures before and during surgery, and a change in surgical practice leading to a 78% reduction in wound infection rates that resulted from a single-center study.

Jerry Dang, MD, of the University of Alberta, Edmonton, reported that the BariWound predictive tool designed to stratify patients into risk categories showed a high level of accuracy with an area under the curve of 0.73. Cynthia Weber, MD, of University Hospitals, Cleveland, reported that changing the method for performing circular-stapled gastrojejunostomy (GJ) from the transoral to the transabdominal approach along with more vigilant use of wound protection reduced wound infection rates from 6% to 1.3%.

Dr. Dang noted that SSI has been reported as the most common hospital-acquired complication in bariatric surgery, with reported rates of between 1% and 10%. A 2014 analysis of the American College of Surgeons National Surgical Quality Improvement Program database reported an SSI rate of 1.8% (Surg Endosc. 2014;28:3285-92). Although these rates are low, Dr. Dang explained that his group wanted to identify factors associated with SSI within 30 days of bariatric surgery. They analyzed outcomes data of 274,187 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database who had bariatric surgery in 2015 and 2016 (196,608 by laparoscopic sleeve gastrectomy [SG] and 77,579 laparoscopic Roux-en-Y gastric bypass [RYGB]). Their analysis determined an incisional SSI rate of 0.47% (n = 1,291). “Incisional SSI rates were four times higher for laparoscopic RYGB: 1.04% vs. 0.25%,” Dr. Dang said.

On multivariable logistic regression, the adjusted odds ratio of SSI after RYGB vs. SG was 3.13 (P less than .001). Other significant risk factors were chronic steroid or immunosuppressant use (odds ratio, 1.75; P = .001), female sex (OR, 1.48; P less than .001) and history of gastroesophageal reflux disease (OR, 1.45; P less than .001). Other factors with a 21%-31% greater risk of SSI were white race (P = .002), history of diabetes (P less than .001), hypertension (P less than .001), obstructive sleep apnea (P = .001), and longer operation times (P less than .001). Each single-digit increase in body mass index increased risk by 3%, and older age actually had a protective effect for unknown reasons, Dr. Dang noted.

The BariWound tool assigns points to each risk factor. Each hour of operation time and each 10 kg/m² of weight carry a value of 1 point, with partial points allowed. RYGB equals 5 points, and chronic steroid/immunosuppressant use, 4 points. The tool assigns risk to four categories based on score and 30-day SSI rate:

• Low, less than 15 (1% risk of SSI).
• Moderate, 15-21.9 (1%-5%).
• High, 22-26.9 (5%-10%).
• Very high, greater than 27 (greater than 10%).

“The BariWound tool can help to inform clinical decision making so patients can know they’re at higher risk, and this could allow for us to target high-risk patients with preventive packages, such as the Cleveland Clinic Technique of wound protection, wound irrigation, and wound packing as a resource-saving measure,” Dr. Dang said. “Targeting high-risk populations can reduce cost and operating time.”

139552_Weber_Cynthia_web.jpg

Dr. Weber reported on her institution’s study of SSIs using two different methods for circular stapling of GJ that involved two different surgeons who performed 333 RYGB procedures from January 2016 to March 2018. Surgeon “A” had traditionally used the transoral technique without wound protection to insert the anvil of the stapler; surgeon “B” used wound protection and the transabdominal technique for stapler insertion. Wound protection involves draping of the stapler with sterile plastic.

“In a quarterly review, we detected a higher than expected wound complication rate of 6%,” Dr. Weber said. “Of particular concern was the development of five recent wound infection cases, which all occurred in the transoral group for a rate of 8.9% in that cohort.”

That left the quality team questioning the safety profile of the transoral technique, Dr. Weber said. “We wanted to know why and whether or not the main contributor to the development of a wound infection was the technique for the anvil introduction or was it the difference between surgeons using wound protection.”

Halfway through the study period, surgeon A made two modifications: He adopted the transabdominal technique for a subset of patients; and because of the surgeon’s comfort level and expertise with the transoral approach, he continued using that approach but added wound protection. Surgeon B continued with the transabdominal approach with wound protection. The share of transabdominal insertions in the study population increased from 69.2% before the change to 75% after. Demographics between the pre- and postchange patient populations were similar, as were the rates of revision surgery between the two groups.

“We noticed a significant reduction in total wound complications from 6% to 1.3%, and we noticed a complete elimination of surgical site infections after adding wound protection to the transoral technique,” Dr. Weber said.

Dr. Weber noted a number of limitations with the study: its retrospective nature; the lack of control for other intraoperative factors that contribute to SSIs; relatively low incidence of SSI; and surgeon’s choice to determine the technique of anvil insertion.

“We found that our quality improvement intervention was efficacious and decided that it was not the technique of anvil insertion, but it was the wound protection that was key to preventing wound infections, as we saw complete elimination after we added wound protection to the transoral technique,” Dr. Weber said. “Using proper precautions with the circular stapler and anastomosis can be done using either technique for anvil insertion. Overall self-assessment of outcomes leads to best practice.”

Dr. Dang had no financial relationships to disclose. Dr. Weber’s coauthor Leena Khatian, MD, MPH, disclosed relationships with Torax Medical, Medtronic, and Gore.

SOURCES: Weber C et al. SAGES 2109, Presentation S049; Dang J et al. SAGES 2019, Presentation S050.

BALTIMORE – While rates of surgical site infections after bariatric surgery have been reported in the low single digits, SSIs have continued to be a persistent complication.

139552_Dang_Jerry_web.jpg

At the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons, researchers reported on two strategies to reduce SSI in bariatric surgery: a predictive tool that identifies risk factors for wound infection, allowing surgeons to employ protective measures before and during surgery, and a change in surgical practice leading to a 78% reduction in wound infection rates that resulted from a single-center study.

Jerry Dang, MD, of the University of Alberta, Edmonton, reported that the BariWound predictive tool designed to stratify patients into risk categories showed a high level of accuracy with an area under the curve of 0.73. Cynthia Weber, MD, of University Hospitals, Cleveland, reported that changing the method for performing circular-stapled gastrojejunostomy (GJ) from the transoral to the transabdominal approach along with more vigilant use of wound protection reduced wound infection rates from 6% to 1.3%.

Dr. Dang noted that SSI has been reported as the most common hospital-acquired complication in bariatric surgery, with reported rates of between 1% and 10%. A 2014 analysis of the American College of Surgeons National Surgical Quality Improvement Program database reported an SSI rate of 1.8% (Surg Endosc. 2014;28:3285-92). Although these rates are low, Dr. Dang explained that his group wanted to identify factors associated with SSI within 30 days of bariatric surgery. They analyzed outcomes data of 274,187 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database who had bariatric surgery in 2015 and 2016 (196,608 by laparoscopic sleeve gastrectomy [SG] and 77,579 laparoscopic Roux-en-Y gastric bypass [RYGB]). Their analysis determined an incisional SSI rate of 0.47% (n = 1,291). “Incisional SSI rates were four times higher for laparoscopic RYGB: 1.04% vs. 0.25%,” Dr. Dang said.

On multivariable logistic regression, the adjusted odds ratio of SSI after RYGB vs. SG was 3.13 (P less than .001). Other significant risk factors were chronic steroid or immunosuppressant use (odds ratio, 1.75; P = .001), female sex (OR, 1.48; P less than .001) and history of gastroesophageal reflux disease (OR, 1.45; P less than .001). Other factors with a 21%-31% greater risk of SSI were white race (P = .002), history of diabetes (P less than .001), hypertension (P less than .001), obstructive sleep apnea (P = .001), and longer operation times (P less than .001). Each single-digit increase in body mass index increased risk by 3%, and older age actually had a protective effect for unknown reasons, Dr. Dang noted.

The BariWound tool assigns points to each risk factor. Each hour of operation time and each 10 kg/m² of weight carry a value of 1 point, with partial points allowed. RYGB equals 5 points, and chronic steroid/immunosuppressant use, 4 points. The tool assigns risk to four categories based on score and 30-day SSI rate:

• Low, less than 15 (1% risk of SSI).
• Moderate, 15-21.9 (1%-5%).
• High, 22-26.9 (5%-10%).
• Very high, greater than 27 (greater than 10%).

“The BariWound tool can help to inform clinical decision making so patients can know they’re at higher risk, and this could allow for us to target high-risk patients with preventive packages, such as the Cleveland Clinic Technique of wound protection, wound irrigation, and wound packing as a resource-saving measure,” Dr. Dang said. “Targeting high-risk populations can reduce cost and operating time.”

139552_Weber_Cynthia_web.jpg

Dr. Weber reported on her institution’s study of SSIs using two different methods for circular stapling of GJ that involved two different surgeons who performed 333 RYGB procedures from January 2016 to March 2018. Surgeon “A” had traditionally used the transoral technique without wound protection to insert the anvil of the stapler; surgeon “B” used wound protection and the transabdominal technique for stapler insertion. Wound protection involves draping of the stapler with sterile plastic.

“In a quarterly review, we detected a higher than expected wound complication rate of 6%,” Dr. Weber said. “Of particular concern was the development of five recent wound infection cases, which all occurred in the transoral group for a rate of 8.9% in that cohort.”

That left the quality team questioning the safety profile of the transoral technique, Dr. Weber said. “We wanted to know why and whether or not the main contributor to the development of a wound infection was the technique for the anvil introduction or was it the difference between surgeons using wound protection.”

Halfway through the study period, surgeon A made two modifications: He adopted the transabdominal technique for a subset of patients; and because of the surgeon’s comfort level and expertise with the transoral approach, he continued using that approach but added wound protection. Surgeon B continued with the transabdominal approach with wound protection. The share of transabdominal insertions in the study population increased from 69.2% before the change to 75% after. Demographics between the pre- and postchange patient populations were similar, as were the rates of revision surgery between the two groups.

“We noticed a significant reduction in total wound complications from 6% to 1.3%, and we noticed a complete elimination of surgical site infections after adding wound protection to the transoral technique,” Dr. Weber said.

Dr. Weber noted a number of limitations with the study: its retrospective nature; the lack of control for other intraoperative factors that contribute to SSIs; relatively low incidence of SSI; and surgeon’s choice to determine the technique of anvil insertion.

“We found that our quality improvement intervention was efficacious and decided that it was not the technique of anvil insertion, but it was the wound protection that was key to preventing wound infections, as we saw complete elimination after we added wound protection to the transoral technique,” Dr. Weber said. “Using proper precautions with the circular stapler and anastomosis can be done using either technique for anvil insertion. Overall self-assessment of outcomes leads to best practice.”

Dr. Dang had no financial relationships to disclose. Dr. Weber’s coauthor Leena Khatian, MD, MPH, disclosed relationships with Torax Medical, Medtronic, and Gore.

SOURCES: Weber C et al. SAGES 2109, Presentation S049; Dang J et al. SAGES 2019, Presentation S050.

BALTIMORE – While rates of surgical site infections after bariatric surgery have been reported in the low single digits, SSIs have continued to be a persistent complication.

139552_Dang_Jerry_web.jpg

At the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons, researchers reported on two strategies to reduce SSI in bariatric surgery: a predictive tool that identifies risk factors for wound infection, allowing surgeons to employ protective measures before and during surgery, and a change in surgical practice leading to a 78% reduction in wound infection rates that resulted from a single-center study.

Jerry Dang, MD, of the University of Alberta, Edmonton, reported that the BariWound predictive tool designed to stratify patients into risk categories showed a high level of accuracy with an area under the curve of 0.73. Cynthia Weber, MD, of University Hospitals, Cleveland, reported that changing the method for performing circular-stapled gastrojejunostomy (GJ) from the transoral to the transabdominal approach along with more vigilant use of wound protection reduced wound infection rates from 6% to 1.3%.

Dr. Dang noted that SSI has been reported as the most common hospital-acquired complication in bariatric surgery, with reported rates of between 1% and 10%. A 2014 analysis of the American College of Surgeons National Surgical Quality Improvement Program database reported an SSI rate of 1.8% (Surg Endosc. 2014;28:3285-92). Although these rates are low, Dr. Dang explained that his group wanted to identify factors associated with SSI within 30 days of bariatric surgery. They analyzed outcomes data of 274,187 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database who had bariatric surgery in 2015 and 2016 (196,608 by laparoscopic sleeve gastrectomy [SG] and 77,579 laparoscopic Roux-en-Y gastric bypass [RYGB]). Their analysis determined an incisional SSI rate of 0.47% (n = 1,291). “Incisional SSI rates were four times higher for laparoscopic RYGB: 1.04% vs. 0.25%,” Dr. Dang said.

On multivariable logistic regression, the adjusted odds ratio of SSI after RYGB vs. SG was 3.13 (P less than .001). Other significant risk factors were chronic steroid or immunosuppressant use (odds ratio, 1.75; P = .001), female sex (OR, 1.48; P less than .001) and history of gastroesophageal reflux disease (OR, 1.45; P less than .001). Other factors with a 21%-31% greater risk of SSI were white race (P = .002), history of diabetes (P less than .001), hypertension (P less than .001), obstructive sleep apnea (P = .001), and longer operation times (P less than .001). Each single-digit increase in body mass index increased risk by 3%, and older age actually had a protective effect for unknown reasons, Dr. Dang noted.

The BariWound tool assigns points to each risk factor. Each hour of operation time and each 10 kg/m² of weight carry a value of 1 point, with partial points allowed. RYGB equals 5 points, and chronic steroid/immunosuppressant use, 4 points. The tool assigns risk to four categories based on score and 30-day SSI rate:

• Low, less than 15 (1% risk of SSI).
• Moderate, 15-21.9 (1%-5%).
• High, 22-26.9 (5%-10%).
• Very high, greater than 27 (greater than 10%).

“The BariWound tool can help to inform clinical decision making so patients can know they’re at higher risk, and this could allow for us to target high-risk patients with preventive packages, such as the Cleveland Clinic Technique of wound protection, wound irrigation, and wound packing as a resource-saving measure,” Dr. Dang said. “Targeting high-risk populations can reduce cost and operating time.”

139552_Weber_Cynthia_web.jpg

Dr. Weber reported on her institution’s study of SSIs using two different methods for circular stapling of GJ that involved two different surgeons who performed 333 RYGB procedures from January 2016 to March 2018. Surgeon “A” had traditionally used the transoral technique without wound protection to insert the anvil of the stapler; surgeon “B” used wound protection and the transabdominal technique for stapler insertion. Wound protection involves draping of the stapler with sterile plastic.

“In a quarterly review, we detected a higher than expected wound complication rate of 6%,” Dr. Weber said. “Of particular concern was the development of five recent wound infection cases, which all occurred in the transoral group for a rate of 8.9% in that cohort.”

That left the quality team questioning the safety profile of the transoral technique, Dr. Weber said. “We wanted to know why and whether or not the main contributor to the development of a wound infection was the technique for the anvil introduction or was it the difference between surgeons using wound protection.”

Halfway through the study period, surgeon A made two modifications: He adopted the transabdominal technique for a subset of patients; and because of the surgeon’s comfort level and expertise with the transoral approach, he continued using that approach but added wound protection. Surgeon B continued with the transabdominal approach with wound protection. The share of transabdominal insertions in the study population increased from 69.2% before the change to 75% after. Demographics between the pre- and postchange patient populations were similar, as were the rates of revision surgery between the two groups.

“We noticed a significant reduction in total wound complications from 6% to 1.3%, and we noticed a complete elimination of surgical site infections after adding wound protection to the transoral technique,” Dr. Weber said.

Dr. Weber noted a number of limitations with the study: its retrospective nature; the lack of control for other intraoperative factors that contribute to SSIs; relatively low incidence of SSI; and surgeon’s choice to determine the technique of anvil insertion.

“We found that our quality improvement intervention was efficacious and decided that it was not the technique of anvil insertion, but it was the wound protection that was key to preventing wound infections, as we saw complete elimination after we added wound protection to the transoral technique,” Dr. Weber said. “Using proper precautions with the circular stapler and anastomosis can be done using either technique for anvil insertion. Overall self-assessment of outcomes leads to best practice.”

Dr. Dang had no financial relationships to disclose. Dr. Weber’s coauthor Leena Khatian, MD, MPH, disclosed relationships with Torax Medical, Medtronic, and Gore.

SOURCES: Weber C et al. SAGES 2109, Presentation S049; Dang J et al. SAGES 2019, Presentation S050.

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – A quality improvement project conducted at the Cleveland Clinic dropped the 30-day colorectal surgery infection rate from 11.8% to 6.6%, driven mostly by a reduction in deep organ space infections from 5.5% to 1.7%.

It was a remarkable finding that got the attention of attendees at the annual clinical congress of the American College of Surgeons. The Cleveland Clinic had been an outlier, in the wrong direction, compared with other centers, and administrators wanted a solution.

I. Emre Gorgun, MD, FACS, a colorectal surgeon and quality improvement officer at Cleveland Clinic, led the search for evidence-based interventions. Eventually, big changes were made to perioperative antibiotics, mechanical bowel prep, preop shower routines, and intraoperative procedures. The efforts paid off (Dis Colon Rectum. 2018 Jan;61[1]:89-98).

To help surgeons lower their own infection rates, Dr. Gorgun agreed to an interview at the meeting to explain exactly what was done.

There was resistance at first from surgeons who wanted to stick with their routines, but they came around once they were shown the data backing the changes. Eventually, “everyone was on board. We believe in this,” Dr. Gorgun said.

aotto@mdedge.com

BOSTON – Deep surgical site infections after retrorectus ventral hernia repair do not necessarily require mesh excision, according to Cleveland Clinic investigators.

Burneikis_Dominykas_OH_web.jpg

When infected mesh is removed, however, there’s a novel approach that avoids the pitfalls of both immediate and staged abdominal wall reconstruction, according to a second team from the Georgetown University, Washington.

The two approaches were offered at the annual clinical congress of the American College of Surgery as alternatives to usual care. Infected ventral hernia mesh is a well-known headache for general surgeons, and management isn’t standardized. Surgeons are keenly alert for new approaches to improve outcomes; the presenters said they hoped their talks would help.

The work “is really pushing this forward, and giving us new data to manage a really vexing problem,” said an audience member.
 

Almost 80% salvageable

Infected meshes are usually removed, but the Cleveland Clinic investigators found that that’s often not necessary.

They reviewed 905 elective ventral hernia repairs at the clinic with synthetic sublay mesh in the retrorectus space. The median hernia width was about 15 cm, and the implanted mesh – usually medium- or heavy-weight polypropylene – had a mean area of 900 cm², “so these were big hernias with a lot of mesh. [Patients] often come to us as a last resort because they’ve been told no elsewhere,” said lead investigator Dominykas Burneikis, MD.

Twenty-four patients (2.7%) developed deep surgical site infections below the anterior rectus fascia. Instead of returning to the OR for new mesh, the team opened, drained, and debrided the wounds, and patients received antibiotics plus negative pressure wound therapy.

Those measures were enough for all but one patient. Mesh was generally found to be granulating well into surrounding tissue, so it was left completely intact in 19 cases (79%), and just trimmed a bit in four others. One man had an excision after his skin flap died and the hernia recurred. At 8 months, 11 patients were completely healed, and 12 had granulating wounds with no visible mesh. There were no cutaneous fistulas.

In short, “we had an 80% mesh salvage rate at 8 months, [which] led us to conclude that most synthetic mesh infections after retrorectus sublay repair do not require explanation,” Dr. Burneikis said.


 

A hybrid approach

When infected mesh does need to come out, abdominal wall reconstruction is either done in the same procedure or months later. Immediate reconstruction generally means operating in a contaminated field, with subsequent rates of wound infection of up to 48%. Delayed closure, meanwhile, means long-term wound care and temporary hernia recurrence, among other problems.

The Georgetown team reported good outcomes with a hybrid approach that combines the benefits of both procedures while avoiding their pitfalls. In the first step, mesh is removed, the abdominal wall debrided, fistulas taken down, and cultures obtained, explained lead investigator and surgery resident Kieranjeet Nijhar, MD.

The wound is temporarily closed with a sterile plastic liner under negative pressure, and patients are taken to the floor for IV antibiotics based on culture results. Three days later, after the infection has been knocked down, the patient is returned to the OR for debridement to healthy tissue and definitive reconstruction with biologic mesh. It’s all done during the same hospitalization.

Dr. Nijhar reviewed 53 cases at Georgetown since 2009. Patients were a mean age of 58 years, with an average body mass index of 35.1 kg/m². Infected mesh was most commonly underlain or retrorectus; mean defect size was 206 cm². Patients spent an average of 11 days in the hospital.

During a mean follow-up of about 9 months, 17 patients (32%) had surgical site problems – infection, dehiscence, hematoma, or seroma – and hernia recurred in six (11.3%); the results compare favorably with especially immediate reconstruction. As in prior studies, higher age and bridge repair were associated with recurrence and methicillin-resistant Staphylococcus aureus (MRSA) infection with surgical site problems.

“We propose this as a potential alternative for” repairs of ventral hernias with infected mesh, Dr. Nijhar said.

Dr. Nijhar and Dr. Burneikis had no relevant disclosures. There was no external funding for the work.
 

aotto@mdedge.com

BOSTON – Deep surgical site infections after retrorectus ventral hernia repair do not necessarily require mesh excision, according to Cleveland Clinic investigators.

Burneikis_Dominykas_OH_web.jpg

When infected mesh is removed, however, there’s a novel approach that avoids the pitfalls of both immediate and staged abdominal wall reconstruction, according to a second team from the Georgetown University, Washington.

The two approaches were offered at the annual clinical congress of the American College of Surgery as alternatives to usual care. Infected ventral hernia mesh is a well-known headache for general surgeons, and management isn’t standardized. Surgeons are keenly alert for new approaches to improve outcomes; the presenters said they hoped their talks would help.

The work “is really pushing this forward, and giving us new data to manage a really vexing problem,” said an audience member.
 

Almost 80% salvageable

Infected meshes are usually removed, but the Cleveland Clinic investigators found that that’s often not necessary.

They reviewed 905 elective ventral hernia repairs at the clinic with synthetic sublay mesh in the retrorectus space. The median hernia width was about 15 cm, and the implanted mesh – usually medium- or heavy-weight polypropylene – had a mean area of 900 cm², “so these were big hernias with a lot of mesh. [Patients] often come to us as a last resort because they’ve been told no elsewhere,” said lead investigator Dominykas Burneikis, MD.

Twenty-four patients (2.7%) developed deep surgical site infections below the anterior rectus fascia. Instead of returning to the OR for new mesh, the team opened, drained, and debrided the wounds, and patients received antibiotics plus negative pressure wound therapy.

Those measures were enough for all but one patient. Mesh was generally found to be granulating well into surrounding tissue, so it was left completely intact in 19 cases (79%), and just trimmed a bit in four others. One man had an excision after his skin flap died and the hernia recurred. At 8 months, 11 patients were completely healed, and 12 had granulating wounds with no visible mesh. There were no cutaneous fistulas.

In short, “we had an 80% mesh salvage rate at 8 months, [which] led us to conclude that most synthetic mesh infections after retrorectus sublay repair do not require explanation,” Dr. Burneikis said.


 

A hybrid approach

When infected mesh does need to come out, abdominal wall reconstruction is either done in the same procedure or months later. Immediate reconstruction generally means operating in a contaminated field, with subsequent rates of wound infection of up to 48%. Delayed closure, meanwhile, means long-term wound care and temporary hernia recurrence, among other problems.

The Georgetown team reported good outcomes with a hybrid approach that combines the benefits of both procedures while avoiding their pitfalls. In the first step, mesh is removed, the abdominal wall debrided, fistulas taken down, and cultures obtained, explained lead investigator and surgery resident Kieranjeet Nijhar, MD.

The wound is temporarily closed with a sterile plastic liner under negative pressure, and patients are taken to the floor for IV antibiotics based on culture results. Three days later, after the infection has been knocked down, the patient is returned to the OR for debridement to healthy tissue and definitive reconstruction with biologic mesh. It’s all done during the same hospitalization.

Dr. Nijhar reviewed 53 cases at Georgetown since 2009. Patients were a mean age of 58 years, with an average body mass index of 35.1 kg/m². Infected mesh was most commonly underlain or retrorectus; mean defect size was 206 cm². Patients spent an average of 11 days in the hospital.

During a mean follow-up of about 9 months, 17 patients (32%) had surgical site problems – infection, dehiscence, hematoma, or seroma – and hernia recurred in six (11.3%); the results compare favorably with especially immediate reconstruction. As in prior studies, higher age and bridge repair were associated with recurrence and methicillin-resistant Staphylococcus aureus (MRSA) infection with surgical site problems.

“We propose this as a potential alternative for” repairs of ventral hernias with infected mesh, Dr. Nijhar said.

Dr. Nijhar and Dr. Burneikis had no relevant disclosures. There was no external funding for the work.
 

aotto@mdedge.com

BOSTON – Deep surgical site infections after retrorectus ventral hernia repair do not necessarily require mesh excision, according to Cleveland Clinic investigators.

Burneikis_Dominykas_OH_web.jpg

When infected mesh is removed, however, there’s a novel approach that avoids the pitfalls of both immediate and staged abdominal wall reconstruction, according to a second team from the Georgetown University, Washington.

The two approaches were offered at the annual clinical congress of the American College of Surgery as alternatives to usual care. Infected ventral hernia mesh is a well-known headache for general surgeons, and management isn’t standardized. Surgeons are keenly alert for new approaches to improve outcomes; the presenters said they hoped their talks would help.

The work “is really pushing this forward, and giving us new data to manage a really vexing problem,” said an audience member.
 

Almost 80% salvageable

Infected meshes are usually removed, but the Cleveland Clinic investigators found that that’s often not necessary.

They reviewed 905 elective ventral hernia repairs at the clinic with synthetic sublay mesh in the retrorectus space. The median hernia width was about 15 cm, and the implanted mesh – usually medium- or heavy-weight polypropylene – had a mean area of 900 cm², “so these were big hernias with a lot of mesh. [Patients] often come to us as a last resort because they’ve been told no elsewhere,” said lead investigator Dominykas Burneikis, MD.

Twenty-four patients (2.7%) developed deep surgical site infections below the anterior rectus fascia. Instead of returning to the OR for new mesh, the team opened, drained, and debrided the wounds, and patients received antibiotics plus negative pressure wound therapy.

Those measures were enough for all but one patient. Mesh was generally found to be granulating well into surrounding tissue, so it was left completely intact in 19 cases (79%), and just trimmed a bit in four others. One man had an excision after his skin flap died and the hernia recurred. At 8 months, 11 patients were completely healed, and 12 had granulating wounds with no visible mesh. There were no cutaneous fistulas.

In short, “we had an 80% mesh salvage rate at 8 months, [which] led us to conclude that most synthetic mesh infections after retrorectus sublay repair do not require explanation,” Dr. Burneikis said.


 

A hybrid approach

When infected mesh does need to come out, abdominal wall reconstruction is either done in the same procedure or months later. Immediate reconstruction generally means operating in a contaminated field, with subsequent rates of wound infection of up to 48%. Delayed closure, meanwhile, means long-term wound care and temporary hernia recurrence, among other problems.

The Georgetown team reported good outcomes with a hybrid approach that combines the benefits of both procedures while avoiding their pitfalls. In the first step, mesh is removed, the abdominal wall debrided, fistulas taken down, and cultures obtained, explained lead investigator and surgery resident Kieranjeet Nijhar, MD.

The wound is temporarily closed with a sterile plastic liner under negative pressure, and patients are taken to the floor for IV antibiotics based on culture results. Three days later, after the infection has been knocked down, the patient is returned to the OR for debridement to healthy tissue and definitive reconstruction with biologic mesh. It’s all done during the same hospitalization.

Dr. Nijhar reviewed 53 cases at Georgetown since 2009. Patients were a mean age of 58 years, with an average body mass index of 35.1 kg/m². Infected mesh was most commonly underlain or retrorectus; mean defect size was 206 cm². Patients spent an average of 11 days in the hospital.

During a mean follow-up of about 9 months, 17 patients (32%) had surgical site problems – infection, dehiscence, hematoma, or seroma – and hernia recurred in six (11.3%); the results compare favorably with especially immediate reconstruction. As in prior studies, higher age and bridge repair were associated with recurrence and methicillin-resistant Staphylococcus aureus (MRSA) infection with surgical site problems.

“We propose this as a potential alternative for” repairs of ventral hernias with infected mesh, Dr. Nijhar said.

Dr. Nijhar and Dr. Burneikis had no relevant disclosures. There was no external funding for the work.
 

aotto@mdedge.com

SAN FRANCISCO – Daptomycin plus fosfomycin is more effective than daptomycin alone for methicillin-resistant Staphylococcus aureus bacteremia, according to a multicenter, randomized trial from Spain.

Pujol_Miquel_Barcelona_web.jpg

“I think this is really an important study; I think it will change clinical practice for this infection” once it’s published, said lead investigator Miquel Pujol, MD, PhD, clinical head of infectious diseases at Bellvitge University Hospital in Barcelona.

The current standard for MRSA bacteremia is daptomycin (Cubicin) or vancomycin (Vancocin) monotherapy on both sides of the Atlantic, but mortality rates are way too high, more than 30% in some reviews. Dr. Pujol and his colleagues wanted to find something better.

Their lab work showed that daptomycin and fosfomycin (Monurol) were synergistic and rapidly bactericidal against MRSA, and anecdotal experience in Spain suggested the drugs improved bacteremia outcomes, so they decided to put the combination to the test.

They randomized 74 MRSA bacteremia patients to the combination, daptomycin 10mg/kg IV daily plus fosfomycin 2g IV q 6h. They randomized 81 other subjects to standard of care with daptomycin monotherapy, also at 10mg/kg IV daily. Treatment was 10-14 days for uncomplicated and 28-42 days for complicated bacteremia.

The open-label trial was conducted at 18 medical centers in Spain, where fosfomycin was discovered in dirt samples in the late 1960s and remains a matter of pride.

At day 7, 69 of the 74 combination patients (93.2%) were alive with clinical improvement, clearance of bacteremia, and no subsequent relapse, versus 62 of 81 patients (76.5%) on monotherapy (absolute difference 16.7%; 95% confidence interval, 5.4%-27.7%). Three people in the combination arm (4.1%) had died by day 7, versus six on monotherapy (7.4%).

Six weeks after the end of treatment at the test-of-cure visit, 40 of 74 combination patients (54.1%) were alive with resolution of all clinical signs and symptoms, negative blood cultures, and no previous or subsequent relapses; just 34 of 81 patients (42%) in the monotherapy arm hit that mark. The 12.1% difference was not statistically significant, nor was the difference in 12-week survival.

However, patients in the combination arm were 70% less likely to have complicated bacteremia at the test-of-cure visit (9.5% vs. 28.4%; relative risk 0.3; 95% CI, 0.2-0.7). There were no cases of persistent or recurrent infection in the combination arm, but nine persistent (11.1%) and five recurrent (6.2%) cases with daptomycin monotherapy. The differences were statistically significant.

The subjects all had at least one positive MRSA blood culture within 72 hours of randomization. Exclusion criteria included MRSA pneumonia, prosthetic valve endocarditis, end-stage liver disease, and moderate to severe heart failure.

There were no significant baseline differences between the groups. About half the subjects were men, and the mean age was about 73 years. The mean Charlson Comorbidity Index score was a bit under 4, and the mean Pitt bacteremia score a bit over 1. The leading source of infection was vascular catheter; acquisition was thought to be nosocomial in more than 40% of patients.

There were no discontinuations from drug side effects in the daptomycin arm, but there were five in the combination arm, including two for heart failure, two for respiratory insufficiency, and one for GI bleeding. Even so, the benefit outweighed the risk, Dr. Pujol said.

Intravenous fosfomycin is available in Europe, but the drug is approved in the United States only as an oral formulation. That could change soon; Nabriva Therapeutics plans to file its IV formulation (Contepo) for Food and Drug Administration approval in late 2018.

Though it is not standard of practice yet, the combination is increasingly being used in Spain for MRSA bacteremia, according to Dr. Pujol. “Patients probably need the combination [at least] initially, especially if they have complicated bacteremia” or fail monotherapy, he said at ID week, an annual scientific meeting on infectious diseases.

The work was funded by the Spanish government. Dr. Pujol said he had no relevant disclosures.
 

aotto@mdedge.com

SOURCE: Pujol M et al. 2018 ID Week abstract LB3

SAN FRANCISCO – Daptomycin plus fosfomycin is more effective than daptomycin alone for methicillin-resistant Staphylococcus aureus bacteremia, according to a multicenter, randomized trial from Spain.

Pujol_Miquel_Barcelona_web.jpg

“I think this is really an important study; I think it will change clinical practice for this infection” once it’s published, said lead investigator Miquel Pujol, MD, PhD, clinical head of infectious diseases at Bellvitge University Hospital in Barcelona.

The current standard for MRSA bacteremia is daptomycin (Cubicin) or vancomycin (Vancocin) monotherapy on both sides of the Atlantic, but mortality rates are way too high, more than 30% in some reviews. Dr. Pujol and his colleagues wanted to find something better.

Their lab work showed that daptomycin and fosfomycin (Monurol) were synergistic and rapidly bactericidal against MRSA, and anecdotal experience in Spain suggested the drugs improved bacteremia outcomes, so they decided to put the combination to the test.

They randomized 74 MRSA bacteremia patients to the combination, daptomycin 10mg/kg IV daily plus fosfomycin 2g IV q 6h. They randomized 81 other subjects to standard of care with daptomycin monotherapy, also at 10mg/kg IV daily. Treatment was 10-14 days for uncomplicated and 28-42 days for complicated bacteremia.

The open-label trial was conducted at 18 medical centers in Spain, where fosfomycin was discovered in dirt samples in the late 1960s and remains a matter of pride.

At day 7, 69 of the 74 combination patients (93.2%) were alive with clinical improvement, clearance of bacteremia, and no subsequent relapse, versus 62 of 81 patients (76.5%) on monotherapy (absolute difference 16.7%; 95% confidence interval, 5.4%-27.7%). Three people in the combination arm (4.1%) had died by day 7, versus six on monotherapy (7.4%).

Six weeks after the end of treatment at the test-of-cure visit, 40 of 74 combination patients (54.1%) were alive with resolution of all clinical signs and symptoms, negative blood cultures, and no previous or subsequent relapses; just 34 of 81 patients (42%) in the monotherapy arm hit that mark. The 12.1% difference was not statistically significant, nor was the difference in 12-week survival.

However, patients in the combination arm were 70% less likely to have complicated bacteremia at the test-of-cure visit (9.5% vs. 28.4%; relative risk 0.3; 95% CI, 0.2-0.7). There were no cases of persistent or recurrent infection in the combination arm, but nine persistent (11.1%) and five recurrent (6.2%) cases with daptomycin monotherapy. The differences were statistically significant.

The subjects all had at least one positive MRSA blood culture within 72 hours of randomization. Exclusion criteria included MRSA pneumonia, prosthetic valve endocarditis, end-stage liver disease, and moderate to severe heart failure.

There were no significant baseline differences between the groups. About half the subjects were men, and the mean age was about 73 years. The mean Charlson Comorbidity Index score was a bit under 4, and the mean Pitt bacteremia score a bit over 1. The leading source of infection was vascular catheter; acquisition was thought to be nosocomial in more than 40% of patients.

There were no discontinuations from drug side effects in the daptomycin arm, but there were five in the combination arm, including two for heart failure, two for respiratory insufficiency, and one for GI bleeding. Even so, the benefit outweighed the risk, Dr. Pujol said.

Intravenous fosfomycin is available in Europe, but the drug is approved in the United States only as an oral formulation. That could change soon; Nabriva Therapeutics plans to file its IV formulation (Contepo) for Food and Drug Administration approval in late 2018.

Though it is not standard of practice yet, the combination is increasingly being used in Spain for MRSA bacteremia, according to Dr. Pujol. “Patients probably need the combination [at least] initially, especially if they have complicated bacteremia” or fail monotherapy, he said at ID week, an annual scientific meeting on infectious diseases.

The work was funded by the Spanish government. Dr. Pujol said he had no relevant disclosures.
 

aotto@mdedge.com

SOURCE: Pujol M et al. 2018 ID Week abstract LB3

SAN FRANCISCO – Daptomycin plus fosfomycin is more effective than daptomycin alone for methicillin-resistant Staphylococcus aureus bacteremia, according to a multicenter, randomized trial from Spain.

Pujol_Miquel_Barcelona_web.jpg

“I think this is really an important study; I think it will change clinical practice for this infection” once it’s published, said lead investigator Miquel Pujol, MD, PhD, clinical head of infectious diseases at Bellvitge University Hospital in Barcelona.

The current standard for MRSA bacteremia is daptomycin (Cubicin) or vancomycin (Vancocin) monotherapy on both sides of the Atlantic, but mortality rates are way too high, more than 30% in some reviews. Dr. Pujol and his colleagues wanted to find something better.

Their lab work showed that daptomycin and fosfomycin (Monurol) were synergistic and rapidly bactericidal against MRSA, and anecdotal experience in Spain suggested the drugs improved bacteremia outcomes, so they decided to put the combination to the test.

They randomized 74 MRSA bacteremia patients to the combination, daptomycin 10mg/kg IV daily plus fosfomycin 2g IV q 6h. They randomized 81 other subjects to standard of care with daptomycin monotherapy, also at 10mg/kg IV daily. Treatment was 10-14 days for uncomplicated and 28-42 days for complicated bacteremia.

The open-label trial was conducted at 18 medical centers in Spain, where fosfomycin was discovered in dirt samples in the late 1960s and remains a matter of pride.

At day 7, 69 of the 74 combination patients (93.2%) were alive with clinical improvement, clearance of bacteremia, and no subsequent relapse, versus 62 of 81 patients (76.5%) on monotherapy (absolute difference 16.7%; 95% confidence interval, 5.4%-27.7%). Three people in the combination arm (4.1%) had died by day 7, versus six on monotherapy (7.4%).

Six weeks after the end of treatment at the test-of-cure visit, 40 of 74 combination patients (54.1%) were alive with resolution of all clinical signs and symptoms, negative blood cultures, and no previous or subsequent relapses; just 34 of 81 patients (42%) in the monotherapy arm hit that mark. The 12.1% difference was not statistically significant, nor was the difference in 12-week survival.

However, patients in the combination arm were 70% less likely to have complicated bacteremia at the test-of-cure visit (9.5% vs. 28.4%; relative risk 0.3; 95% CI, 0.2-0.7). There were no cases of persistent or recurrent infection in the combination arm, but nine persistent (11.1%) and five recurrent (6.2%) cases with daptomycin monotherapy. The differences were statistically significant.

The subjects all had at least one positive MRSA blood culture within 72 hours of randomization. Exclusion criteria included MRSA pneumonia, prosthetic valve endocarditis, end-stage liver disease, and moderate to severe heart failure.

There were no significant baseline differences between the groups. About half the subjects were men, and the mean age was about 73 years. The mean Charlson Comorbidity Index score was a bit under 4, and the mean Pitt bacteremia score a bit over 1. The leading source of infection was vascular catheter; acquisition was thought to be nosocomial in more than 40% of patients.

There were no discontinuations from drug side effects in the daptomycin arm, but there were five in the combination arm, including two for heart failure, two for respiratory insufficiency, and one for GI bleeding. Even so, the benefit outweighed the risk, Dr. Pujol said.

Intravenous fosfomycin is available in Europe, but the drug is approved in the United States only as an oral formulation. That could change soon; Nabriva Therapeutics plans to file its IV formulation (Contepo) for Food and Drug Administration approval in late 2018.

Though it is not standard of practice yet, the combination is increasingly being used in Spain for MRSA bacteremia, according to Dr. Pujol. “Patients probably need the combination [at least] initially, especially if they have complicated bacteremia” or fail monotherapy, he said at ID week, an annual scientific meeting on infectious diseases.

The work was funded by the Spanish government. Dr. Pujol said he had no relevant disclosures.
 

aotto@mdedge.com

SOURCE: Pujol M et al. 2018 ID Week abstract LB3

SAN FRANCISCO – Clinicians prescribed 46% of antibiotics without an infection-related diagnosis code and 20% without an office visit, based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.

The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.

Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.

The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.

“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.

With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.

Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.

Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.

The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.

The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
 

SOURCE: Linder JA et al. ID Week 2018 abstract 1632.

aotto@mdedge.com

SAN FRANCISCO – Clinicians prescribed 46% of antibiotics without an infection-related diagnosis code and 20% without an office visit, based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.

The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.

Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.

The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.

“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.

With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.

Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.

Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.

The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.

The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
 

SOURCE: Linder JA et al. ID Week 2018 abstract 1632.

aotto@mdedge.com

SAN FRANCISCO – Clinicians prescribed 46% of antibiotics without an infection-related diagnosis code and 20% without an office visit, based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.

The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.

Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.

The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.

“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.

With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.

Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.

Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.

The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.

The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
 

SOURCE: Linder JA et al. ID Week 2018 abstract 1632.

aotto@mdedge.com