To compare the occurrence of superficial surgical site infections in obese women using prophylactic negative pressure therapy with standard dressings after cesarean delivery.
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.
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).
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.
Prophylactic negative pressure wound therapy does not reduce the rate of superficial surgical site infection after cesarean delivery in women with class II or III obesity.
Departments of Obstetrics and Gynecology and Biomedical Data Science and the Dartmouth Institute for Health Policy and Clinical Practice, the Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.
Corresponding author: Kristina A. Wihbey, MD, Department of Obstetrics and Gynecology, The Geisel School of Medicine at Dartmouth, 189 N Main Street, Concord, NH 03301; email: firstname.lastname@example.org.
Financial Disclosure The authors did not report any potential conflicts of interest.
The devices used in this study were provided by an unrestricted research grant from KCI Medical (San Antonio, Texas). KCI Medical had no role in the study design, data collection, or data analysis. Final results of the study were shared with the company before manuscript submission; however, the investigators were not bound to incorporate KCI's comments. The authors' decision as to what the manuscript contained was final.
Each author has indicated that he or she has met the journal's requirements for authorship.
Received February 06, 2018
Received in revised form May 04, 2018
Accepted May 15, 2018