A barrier retractor to reduce surgical site infections and wound disruptions in obese patients undergoing cesarean delivery: a randomized controlled trial

BACKGROUND: Surgical site infections (SSIs) are an important cause of morbidity following cesarean delivery, particularly in obese patients. Methods to reduce SSIs after cesarean delivery would have an important impact in obese obstetric patients. OBJECTIVE: The purpose of this study was to determine whether the AlexisO cesarean delivery retractor, a barrier self-retaining retractor, reduces SSIs and wound disruptions in obese patients undergoing cesarean delivery. STUDY DESIGN: This was a randomized controlled trial of obese women (body mass index >= 30 kg/m(2)) undergoing nonemergent cesarean delivery. Patients were randomized to the treatment group (using the Alexis O cesarean delivery retractor) or to the control group (using conventional handheld retractors). The primary outcome was SSI or wound disruption during the 30 day postoperative period. Secondary outcomes included operative time, estimated blood loss, change in hemoglobin, antiemetic use, length of postoperative hospital stay, hospital readmission, and other postoperative complications. RESULTS: A total of 301 patients were enrolled in the study. One hundred forty-four patients were randomized to the treatment group and 157 to the control group. Baseline characteristics and indications for cesarean delivery were similar between the 2 groups. Median body mass index was 40.1 kg/m(2). There were no significant differences between the treatment and the control group in the primary outcome of SSI or wound disruption rates at the 30 day assessment (20.6% vs 17.6%, P =.62), during the postoperative inpatient hospitalization or at the 1-2 week postoperative visit. There were also no differences in the primary outcome when adjusting for obesity class or thickness of the subcuticular layer. Patients in the treatment group had lower rates of uterine exteriorization (54.3% vs 87.3%, P <.001), but there were no differences in all other outcomes. CONCLUSION: Use of the Alexis retractor in cesarean delivery deliveries did not decrease SSI or wound disruption rates in an obese population. Its use as a retractor should be left to the discretion of the surgeon and clinical circumstances.