Changing gloves before closure cut wound-related cesarean complications

 

SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.

Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.

Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .

Kari Oakes/Frontline Medical News

The most common complications with cesarean deliveries are wound related, including wound infections and cellulitis, as well as noninfectious complications such as seromas, hematomas, and wound dehiscence. The nature of the procedure increases the risk of lower genital tract bacteria being transferred to an operative field that otherwise would be sterile. Though it makes sense to think about surgeons’ and assistants’ gloves as potential culprits in bacterial transfer, previous work had not shown that intraoperative glove changes decreased the rate of postcesarean endometritis, said coauthor Jonathan Scrafford, MD, an ob.gyn. at the University of Minnesota–Minneapolis, who presented the study results at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.

Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.

The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.

The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.

A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.

Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.

Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).

The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.

There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.

The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.

The study authors reported no outside sources of funding and no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes

 

SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.

Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.

Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .

Kari Oakes/Frontline Medical News

The most common complications with cesarean deliveries are wound related, including wound infections and cellulitis, as well as noninfectious complications such as seromas, hematomas, and wound dehiscence. The nature of the procedure increases the risk of lower genital tract bacteria being transferred to an operative field that otherwise would be sterile. Though it makes sense to think about surgeons’ and assistants’ gloves as potential culprits in bacterial transfer, previous work had not shown that intraoperative glove changes decreased the rate of postcesarean endometritis, said coauthor Jonathan Scrafford, MD, an ob.gyn. at the University of Minnesota–Minneapolis, who presented the study results at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.

Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.

The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.

The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.

A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.

Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.

Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).

The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.

There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.

The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.

The study authors reported no outside sources of funding and no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes

 

SAN DIEGO – Changing gloves before closure during cesarean deliveries can reduce overall wound morbidity, a study showed.

Glove changing during the study had a number needed to treat (NNT) of 14 to see benefit, no demonstrated risk, and a total cost per procedure of about $5.

Researchers led by Buvana Reddy, MD, an ob.gyn. in group practice in Woodbury, Minn., used a randomized trial design to determine whether donning a fresh pair of gloves makes a difference in the rate of surgical complications during cesarean delivery. .

Kari Oakes/Frontline Medical News

The most common complications with cesarean deliveries are wound related, including wound infections and cellulitis, as well as noninfectious complications such as seromas, hematomas, and wound dehiscence. The nature of the procedure increases the risk of lower genital tract bacteria being transferred to an operative field that otherwise would be sterile. Though it makes sense to think about surgeons’ and assistants’ gloves as potential culprits in bacterial transfer, previous work had not shown that intraoperative glove changes decreased the rate of postcesarean endometritis, said coauthor Jonathan Scrafford, MD, an ob.gyn. at the University of Minnesota–Minneapolis, who presented the study results at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

Just one previous study had shown a reduced wound infection rate when gloves were changed after placental delivery (J Reprod Med. 2004 Jan;49[1]:13-6). The study showed a statistically significant drop in wound infections, but Dr. Scrafford said that the sample size was small, and the point at which glove changing was performed is not very practical in terms of the flow of surgery.

Building on this study, Dr. Scrafford and his colleagues designed a trial that was meant to be larger, incorporated a composite wound outcome score rather than just focusing strictly on infection, and switched the timing of glove change to just before abdominal closure.

The randomized controlled trial included all women who underwent nonemergent cesarean delivery at the investigators’ home facility during a 15-month period. The patient allocation was not known until the presurgical “time-out.” Patients allocated to the control condition did not have any change in operative procedures; the surgical team of patients allocated to the intervention arm changed their outer gloves immediately before peritoneal or fascial closure.

The composite primary outcome measure assessed wound seroma, hematoma, or dehiscence (defined as a separation of at least 1 cm), as well as wound infection and any other wound abnormality. Secondary outcome measures included whether patients had a fever or peri-incisional cellulitis.

A total of 553 patients were randomized. Follow-up was high, so Dr. Scrafford and his colleagues were able to analyze data from a total of 250 patients in the control arm and 236 patients who received the glove-changing intervention.

Patient demographics and comorbidities were similar between groups, as was the surgical time and estimated blood loss. Dr. Scrafford noted that significantly more patients in the glove-changing group than in the control group received presurgical vaginal preparation with antiseptic solution (20.3% vs. 10.5%; P = .001). However, he reported, statistical analysis showed that this difference had no effect on the results.

Overall, 15 (6.4%) of the patients in the glove-changing group met the criteria for wound complication, compared with 34 (13.6%) in the control group (P = .008). Of the individual components of the primary outcome measure, the difference in incidence of skin separation was also significant; separation was experienced by five patients (2.1%) in the glove-changing group, compared with 14 (5.6%) in the control group (P = .01).

The rate of wound infections was numerically lower in the intervention group, compared with the control group (8 vs. 14), but the difference was not statistically significant.

There were no significant differences between the groups when secondary outcomes were analyzed, Dr. Scrafford said.

The lack of block randomization in the study left open the potential for historical bias, Dr. Scrafford said. Since surgeons couldn’t be blinded as to study arm, the potential for observer bias also existed. Still, he said, the study’s strengths included its large size, and the real-world applicability of the broad inclusion criteria and diverse patient population.

The study authors reported no outside sources of funding and no conflicts of interest.

koakes@frontlinemedcom.com

On Twitter @karioakes