Department of Obstetrics & Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.
Obstet Gynecol. 2019 Oct;134(4):781-789. doi: 10.1097/AOG.0000000000003465.
To evaluate the efficacy of incisional negative pressure wound therapy in the prevention of postoperative wound morbidity in women with class III obesity undergoing cesarean delivery.
In an open label randomized controlled trial, women admitted for delivery with class III obesity (body mass index 40 or higher) measured within 2 weeks of admission for delivery were offered participation in the study. They were consented either in the outpatient maternal-fetal medicine specialty clinic, during admission to labor and delivery and before a decision to perform cesarean delivery, or in the preoperative area of the hospital before scheduled cesarean delivery. Exclusion criteria included anticoagulation therapy, human immunodeficiency virus infection, and silver or acrylic allergy. Those who ultimately underwent cesarean delivery were randomized to standard surgical dressing or incisional negative pressure wound therapy dressing. The primary outcome was wound morbidity. Preplanned secondary outcomes included characteristics of composite wound morbidity, and hospital, emergency room, and clinic utilization. The sample size estimate required randomization of 440 women to detect a 50% decrease in composite outcome.
Between January 1, 2015, and July 31, 2016, 850 women were screened and 677 women with class III obesity were enrolled. Of these, 441 underwent cesarean delivery and were subsequently randomized (219 to standard dressing and 222 to incisional negative pressure wound therapy). The primary outcome, overall composite wound morbidity rate, was 18%. This was not different between the two cohorts (incisional negative pressure wound therapy 17% vs standard dressing 19%, relative risk 0.9 [95% CI 0.5-1.4]).
Prophylactic incisional negative pressure wound therapy use did not reduce postoperative wound morbidity when compared with a standard surgical dressing in women with class III obesity.
ClinicalTrials.gov, NCT02289157.
评估切口负压伤口疗法在预防行剖宫产术的 III 类肥胖女性术后伤口并发症中的疗效。
在一项开放标签、随机对照试验中，对在分娩前 2 周内接受 III 类肥胖（体重指数≥40）测量的入院分娩女性进行研究。她们可以在门诊产妇-胎儿医学专科诊所、在进入分娩和决定行剖宫产术之前、或在计划剖宫产术前的医院手术室区域内同意参加研究。排除标准包括抗凝治疗、人类免疫缺陷病毒感染和对银或丙烯酸过敏。最终行剖宫产术的女性被随机分为标准手术敷料或切口负压伤口疗法敷料。主要结局为伤口并发症。预设的次要结局包括复合伤口并发症的特征以及医院、急诊室和诊所的利用情况。估计需要随机分配 440 名女性，以检测复合结局减少 50%。
2015 年 1 月 1 日至 2016 年 7 月 31 日，共筛查了 850 名女性，其中 677 名患有 III 类肥胖症并被纳入研究。其中 441 名女性接受了剖宫产术，随后被随机分组（标准敷料组 219 例，切口负压伤口疗法组 222 例）。主要结局（整体复合伤口并发症发生率）为 18%。两组之间无差异（切口负压伤口疗法组 17%，标准敷料组 19%，相对风险 0.9 [95%CI 0.5-1.4]）。
与标准手术敷料相比，预防性使用切口负压伤口疗法并不能降低 III 类肥胖女性术后伤口并发症的发生率。
ClinicalTrials.gov，NCT02289157。
