Objective: To compare the occurrence of superficial surgical site infections in obese women using prophylactic negative pressure therapy with standard dressings after cesarean delivery.
Methods: We conducted a randomized controlled, nonblinded, two-center study of prophylactic negative pressure therapy compared with standard surgical dressings placed at the time of primary closure at cesarean delivery in obese women with body mass indexes (BMI) of 35 or higher (ie, class II and III obesity). Our primary outcome was occurrence of a superficial surgical site infection. We assumed a superficial surgical site infection occurrence rate of 20% and intended to recruit 400 women. However, after low enrollment of 166 women over 24 months, an interim analysis for futility was conducted and the decision was made to halt the study.
Results: Women were recruited between January 5, 2015, and January 7, 2017, from two sites. The mean BMI on admission was 44.9 (±8) for the prophylactic negative wound therapy group and 43.4 (±7) for the standard dressing group. There were no differences in the occurrence of observed superficial surgical site infections between women using prophylactic negative pressure wound therapy (12/80 [15%]) compared with women who received the standard dressing (8/81 [10%], P=.35, relative risk 1.52, 95% CI 0.66-3.52). There were no differences in the occurrence of composite wound complications between women using prophylactic negative pressure wound therapy (25/80 [31%]) compared with women who received the standard dressing (24/81 [30%], P=.87).
Conclusion: In this randomized controlled trial that did not achieve full anticipated enrollment, we did not observe a decrease in superficial surgical site infections after cesarean delivery in obese women with the use of prophylactic negative pressure wound therapy.
Clinical trial registration: ClinicalTrials.gov, NCT02390401.