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

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Tuuli reported receiving grants from the National Institutes of Health (NIH) and Acelity. Dr Liu reported receiving grants from the NIH. Dr Tita reported receiving grants from National Institute of Child Health and Human Development (NICHD). Dr Warren reported receiving grants from the NIH; personal fees from CareFusion/BD, PDI Inc, Pursuit Vascular Inc, and Homburg & Partner. Dr Colditz reported receiving grants from the NIH and grants and nonfinancial support from Acelity. Dr Harper reported receiving grants from the NICHD and nonfinancial support from Acelity. No other disclosures were reported.

Figures

Figure 1.. Flow of Study Participants in a Trial of Negative Pressure Wound Therapy After Cesarean Delivery

aOther reasons for exclusion include patients not approached because study staff were unavailable (n = 354), missed by staff (n = 60), emergency delivery (n = 40), and physician refusal (n = 11).

Figure 2.. Subgroup Analysis of the Primary Outcomea

aPrespecified (site, BMI category, scheduled vs unscheduled cesarean delivery, skin incision type, diabetes status) and post hoc (race, primary physician). P values for interaction are from the Breslow-Day test. BMI indicates body mass index, calculated as weight in kilograms divided by height in meters squared.