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.

作者: Methodius G. Tuuli , Jingxia Liu , Alan T. N. Tita , Sherri Longo , Amanda Trudell

DOI: 10.1001/JAMA.2020.13361

关键词:

摘要: 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 infection after in obese women. Objective To evaluate therapy, initiated immediately delivery, lowers infections compared with standard dressing Design, Setting, Participants Multicenter randomized trial conducted from February 8, 2017, through November 13, 2019, at 4 academic 2 community hospitals across United States. Obese women undergoing planned or unplanned were eligible. The study was terminated 1624 2850 participants recruited when a interim analysis showed increased adverse events group futility for primary outcome. Final follow-up December 18, 2019. Interventions randomly assigned to either undergo application device repair surgical incision (n = 816), receive (n = 808). Main Outcomes Measures outcome superficial deep according Centers Disease Control Prevention definitions. Secondary outcomes included other complications, composite skin reactions. Results Of (mean age, 30.4 years, mean body mass index, 39.5), 1608 (99%) completed study: 806 (median duration pressure, days) 802 group. Superficial diagnosed 29 (3.6%) 27 (3.4%) (difference, 0.36%; 95% CI, −1.46% 2.19%,P = .70). 30 prespecified secondary end points, 25 no significant differences, including complications (2.6% vs 3.1%; difference, −0.53%; −1.93% 0.88%;P = .46) (6.5% 6.7%; −0.27%; −2.71% 2.25%;P = .83). Adverse reactions significantly more frequent (7.0% 0.6%; 6.95%; 1.86% 12.03%;P  Conclusions Relevance Among dressing, did not reduce These findings do support routine use delivery. Trial Registration ClinicalTrials.gov Identifier:NCT03009110

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