Effect of Prophylactic Negative Pressure Wound Therapy vs Standard Wound Dressing on Surgical-Site Infection in Obese Women After Cesarean Delivery: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 324; no. 12; pp. 1180 - 1189
• Main Authors: Tuuli, Methodius G, Liu, Jingxia, Tita, Alan T. N, Longo, Sherri, Trudell, Amanda, Carter, Ebony B, Shanks, Anthony, Woolfolk, Candice, Caughey, Aaron B, Warren, David K, Odibo, Anthony O, Colditz, Graham, Macones, George A, Harper, Lorie
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 22-09-2020
• Subjects: Adult; Anti-Bacterial Agents - therapeutic use; Bandages - adverse effects; Blister - etiology; Body mass; Body Mass Index; Body size; Cesarean section; Cesarean Section - adverse effects; Cesarean Section - methods; Clinical trials; Complications; Disease control; Female; Health risks; Humans; Infections; Negative-Pressure Wound Therapy - adverse effects; Obesity; Original Investigation; Pregnancy; Pregnancy Complications; Pressure; Pressure effects; Risk; Skin; Surgical dressings; Surgical site infections; Surgical Wound Infection - prevention & control; Therapy; Wound healing
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2020.13361

IMPORTANCE: Obesity increases the risk of both cesarean delivery and surgical-site infection. Despite widespread use, it is unclear whether prophylactic negative pressure wound therapy reduces surgical-site infection after cesarean delivery in obese women. OBJECTIVE: To evaluate whether prophylactic negative pressure wound therapy, initiated immediately after cesarean delivery, lowers the risk of surgical-site infections compared with standard wound dressing in obese women. DESIGN, SETTING, AND PARTICIPANTS: Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic and 2 community hospitals across the United States. Obese women undergoing planned or unplanned cesarean delivery were eligible. The study was terminated after 1624 of 2850 participants were recruited when a planned interim analysis showed increased adverse events in the negative pressure group and futility for the primary outcome. Final follow-up was December 18, 2019. INTERVENTIONS: Participants were randomly assigned to either undergo prophylactic negative pressure wound therapy, with application of the negative pressure device immediately after repair of the surgical incision (n = 816), or receive standard wound dressing (n = 808). MAIN OUTCOMES AND MEASURES: The primary outcome was superficial or deep surgical-site infection according to the Centers for Disease Control and Prevention definitions. Secondary outcomes included other wound complications, composite of surgical-site infections and other wound complications, and adverse skin reactions. RESULTS: Of the 1624 women randomized (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed the study: 806 in the negative pressure group (median duration of negative pressure, 4 days) and 802 in the standard dressing group. Superficial or deep surgical-site infection was diagnosed in 29 participants (3.6%) in the negative pressure group and 27 (3.4%) in the standard dressing group (difference, 0.36%; 95% CI, −1.46% to 2.19%, P = .70). Of 30 prespecified secondary end points, 25 showed no significant differences, including other wound complications (2.6% vs 3.1%; difference, −0.53%; 95% CI, −1.93% to 0.88%; P = .46) and composite of surgical-site infections and other wound complications (6.5% vs 6.7%; difference, −0.27%; 95% CI, −2.71% to 2.25%; P = .83). Adverse skin reactions were significantly more frequent in the negative pressure group (7.0% vs 0.6%; difference, 6.95%; 95% CI, 1.86% to 12.03%; P < .001). CONCLUSIONS AND RELEVANCE: Among obese women undergoing cesarean delivery, prophylactic negative pressure wound therapy, compared with standard wound dressing, did not significantly reduce the risk of surgical-site infection. These findings do not support routine use of prophylactic negative pressure wound therapy in obese women after cesarean delivery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03009110