Obstetrics and Gynecology, Northwell Health, Huntington, New York.
Global Clinical and Medical Affairs, Smith + Nephew, Hull, United Kingdom.
Am J Perinatol. 2024 May;41(S 01):e2786-e2798. doi: 10.1055/s-0043-1775562. Epub 2023 Sep 19.
This paper aims to evaluate whether there is a device-dependent effect on the reduction of surgical site complications in obese patients (body mass index [BMI] ≥ 30 kg/m) undergoing cesarean section (C-section). PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched for the period, January 2011 to September 2021. English language articles describing a randomized controlled trial (RCT) that compared either a -80 or -125 mm Hg single-use negative pressure wound therapy (sNPWT) device to standard dressings in obese (BMI ≥ 30 kg/m) patients undergoing C-section were included. Conference abstracts and "terminated" RCTs with published results were deemed eligible for inclusion. The primary outcome of interest was surgical site infection (SSI), classified as composite, superficial, or deep. Secondary outcomes assessed included seroma, dehiscence, hematoma, bleeding, reoperation, readmission, blistering, and (composite) wound complications. A total of 223 titles were identified, of which 129 were screened by full-text review. Eleven RCTs encompassing 5,847 patients met the inclusion criteria and were considered eligible for further analysis (-80 mm Hg: six studies; -125 mm Hg: five studies). A statistically significant improvement in the composite SSI (odds ratio [OR]: 0.69; 95% confidence interval [CI]: 0.54-0.89) and superficial SSI (OR: 0.66; 95% CI: 0.50-0.86) outcomes was observed with the -80 mm Hg device, compared with standard dressings. The same effect on SSI outcomes was not observed with the -125 mm Hg device (composite SSI-OR: 0.91; 95% CI: 0.64-1.28; superficial SSI-OR: 1.12; 95% CI: 0.70-1.78). There were no statistically significant differences in any of the other assessed outcomes. sNPWT devices may differ in their ability to reduce composite or superficial SSI after C-section. KEY POINTS: · Negative pressure benefits obese patients undergoing C-section.. · Negative pressure devices may differ in performance.. · A head-to-head clinical trial is needed..
这篇论文旨在评估在接受剖宫产术(C -section)的肥胖患者(体重指数 [BMI]≥30kg/m)中,是否存在与设备相关的减少手术部位并发症的效果。我们检索了 PubMed、Embase、Cochrane 图书馆和 ClinicalTrials.gov,检索时间为 2011 年 1 月至 2021 年 9 月。纳入的英文文章描述了一项随机对照试验(RCT),该试验比较了-80 或-125mmHg 一次性使用负压伤口治疗(sNPWT)设备与肥胖(BMI≥30kg/m)患者接受 C 段手术时的标准敷料。会议摘要和具有公布结果的“终止”RCT 被认为符合纳入标准。主要观察结果是手术部位感染(SSI),分为复合、浅表或深部。评估的次要结果包括血清肿、裂开、血肿、出血、再次手术、再入院、水疱和(复合)伤口并发症。共确定了 223 个标题,其中 129 个进行了全文审查。11 项 RCT 共纳入 5847 例患者,符合进一步分析的纳入标准(-80mmHg:6 项研究;-125mmHg:5 项研究)。与标准敷料相比,-80mmHg 设备可显著改善复合 SSI(优势比[OR]:0.69;95%置信区间[CI]:0.54-0.89)和浅表 SSI(OR:0.66;95%CI:0.50-0.86)结局。-125mmHg 设备对 SSI 结局没有相同的影响(复合 SSI-OR:0.91;95%CI:0.64-1.28;浅表 SSI-OR:1.12;95%CI:0.70-1.78)。其他评估结果无统计学差异。sNPWT 设备在 C 段手术后减少复合或浅表 SSI 的能力可能不同。关键点:·负压有益于接受 C 节段手术的肥胖患者。·负压设备的性能可能存在差异。·需要进行头对头临床试验。