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.

中文翻译：

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预防性负压伤口治疗与标准伤口敷料对剖宫产后肥胖女性手术部位感染的影响

重要性 肥胖会增加剖宫产和手术部位感染的风险。尽管广泛使用，但尚不清楚预防性负压伤口治疗是否能减少肥胖女性剖宫产后的手术部位感染。目的评估与标准伤口敷料相比，剖宫产后立即开始的预防性负压伤口治疗是否能降低肥胖女性手术部位感染的风险。设计、设置和参与者多中心随机试验于 2017 年 2 月 8 日至 2019 年 11 月 13 日在美国的 4 家学术医院和 2 家社区医院进行。接受计划内或计划外剖宫产的肥胖妇女符合条件。该研究在招募了 2850 名参与者中的 1624 名后终止，当时计划的中期分析显示负压组的不良事件增加且主要结果无效。最终随访时间为 2019 年 12 月 18 日。干预措施 参与者被随机分配接受预防性负压伤口治疗，在手术切口修复后立即应用负压装置（n = 816），或接受标准伤口敷料（ n = 808)。主要结果和措施 根据疾病控制和预防中心的定义，主要结果是浅表或深部手术部位感染。次要结局包括其他伤口并发症、手术部位感染和其他伤口并发症的复合以及皮肤不良反应。结果 在随机分组的 1624 名女性中（平均年龄 30.4 岁，平均体重指数 39.5），1608 名（99%）完成了研究：负压组 806 名（负压中位持续时间 4 天）和 802 名标准敷料组。负压组 29 名参与者 (3.6%) 和标准敷料组 27 名参与者 (3.4%) 被诊断为浅表或深部手术部位感染（差异，0.36%；95% CI，-1.46% 至 2.19%，P = .70)。在 30 个预先设定的次要终点中，25 个没有显着差异，包括其他伤口并发症（2.6% vs 3.1%；差异，-0.53%；95% CI，-1.93% 至 0.88%；P = .46）和复合手术部位感染和其他伤口并发症（6.5% vs 6.7%；差异，-0.27%；95% CI，-2.71% 至 2.25%；P = .83）。负压组的皮肤不良反应明显更频繁（7.0% vs 0.6%；差异，6.95%；95% CI，1.86% 至 12.03%；P < .001）。结论和相关性 在接受剖宫产的肥胖女性中，与标准伤口敷料相比，预防性负压伤口治疗并未显着降低手术部位感染的风险。这些发现不支持剖宫产后肥胖妇女常规使用预防性负压伤口治疗。试验注册 ClinicalTrials.gov 标识符：NCT03009110。并没有显着降低手术部位感染的风险。这些发现不支持剖宫产后肥胖妇女常规使用预防性负压伤口治疗。试验注册 ClinicalTrials.gov 标识符：NCT03009110。并没有显着降低手术部位感染的风险。这些发现不支持剖宫产后肥胖妇女常规使用预防性负压伤口治疗。试验注册 ClinicalTrials.gov 标识符：NCT03009110。