Effect of intra-operative glove changing during cesarean section on post-operative complications: a randomized controlled trial.

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To compare the rates of wound-related complications among women undergoing a cesarean section when the surgical team used intra-operative glove changing versus usual care. All women undergoing a cesarean section at a single, county hospital were randomized to usual care or intra-operative glove changing prior to abdominal closure. Participants were randomized at the time of decision for cesarean section; surgeons were not blinded to the randomization arm. The primary outcome was any wound-related complication, including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8weeks of surgery. To detect a reduction in the primary outcome from 17% in the control group to 9% in the intervention group with 80% power, a total of 554 women (277 per group) were required. Secondary outcomes included other infectious complications including endometritis and other superficial or deep soft tissue infections. From August 2015 to November 2016, 277 women were randomized to usual care and 276 women were randomized to intra-operative glove changing. The two groups were well balanced in terms of demographic data, comorbid conditions and surgical characteristics. Intra-operative glove changing led to a significant decrease in composite wound complications from 13.6% in the control group to 6.4% in the intervention group (p = 0.008). Intra-operative glove changing prior to abdominal closure during cesarean section significantly reduced the incidence of post-operative wound complications.