Closed-Incision Negative-Pressure Therapy in Obese Patients Undergoing Cesarean Delivery: A Randomized Controlled Trial

Abstract

<b>Background</b> Postcesarean wound morbidity is a costly complication of cesarean delivery for which preventative strategies remain understudied. <b>Objective</b> We compared surgical site occurrences (SSOs) in cesarean patients receiving closed-incision negative-pressure therapy (ciNPT) or standard-of-care (SOC) dressing. <b>Study Design</b> A single-center randomized controlled trial compared ciNPT (5-7 days) to SOC dressing (1-2 days) in obese women (body mass index [BMI] ≥ 35), undergoing cesarean delivery between 2012 and 2014. Participants were randomized 1:1 and monitored 42 ± 10 days postoperatively. The primary outcome SSOs included unanticipated local inflammation, wound infection, seroma, hematoma, dehiscence, and need for surgical or antibiotic intervention. <b>Results</b> Of the 92 randomized patients, 82 completed the study. ciNPT and SOC groups had similar baseline characteristics. Mean BMI was 46.5 ± 6.5 and no treatment-related serious adverse events. Compared with SOC, the ciNPT group had fewer SSOs (7/43 [16.3%] vs. 2/39 [5.1%], respectively; <i>p </i> = 0.16); significantly fewer participants with less incisional pain both at rest (39/46 [84.8%] vs. 20/46 [43.5%]; <i>p</i> < 0.001) and with incisional pressure (42/46 [91.3%] vs. 25/46 [54.3%]; <i>p </i> < 0.001); and a 30% decrease in total opioid use (79.1 vs. 55.9 mg morphine equivalents, <i>p </i> = 0.036). <b>Conclusion</b> A trend in SSO reduction and a statistically significant reduction in postoperative pain and narcotic use was observed in women using ciNPT.