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一种用于减少肥胖产妇剖宫产手术部位感染和伤口破裂的屏障牵开器:一项随机对照试验。

A barrier retractor to reduce surgical site infections and wound disruptions in obese patients undergoing cesarean delivery: a randomized controlled trial.

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, St Louis University School of Medicine, St Louis, MO.

Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, St Louis University School of Medicine, St Louis, MO.

出版信息

Am J Obstet Gynecol. 2016 Feb;214(2):285.e1-285.e10. doi: 10.1016/j.ajog.2015.09.096. Epub 2015 Oct 9.

Abstract

BACKGROUND

Surgical site infections (SSIs) are an important cause of morbidity following cesarean delivery, particularly in obese patients. Methods to reduce SSIs after cesarean delivery would have an important impact in obese obstetric patients.

OBJECTIVE

The purpose of this study was to determine whether the Alexis O cesarean delivery retractor, a barrier self-retaining retractor, reduces SSIs and wound disruptions in obese patients undergoing cesarean delivery.

STUDY DESIGN

This was a randomized controlled trial of obese women (body mass index ≥ 30 kg/m(2)) undergoing nonemergent cesarean delivery. Patients were randomized to the treatment group (using the Alexis O cesarean delivery retractor) or to the control group (using conventional handheld retractors). The primary outcome was SSI or wound disruption during the 30 day postoperative period. Secondary outcomes included operative time, estimated blood loss, change in hemoglobin, antiemetic use, length of postoperative hospital stay, hospital readmission, and other postoperative complications.

RESULTS

A total of 301 patients were enrolled in the study. One hundred forty-four patients were randomized to the treatment group and 157 to the control group. Baseline characteristics and indications for cesarean delivery were similar between the 2 groups. Median body mass index was 40.1 kg/m(2). There were no significant differences between the treatment and the control group in the primary outcome of SSI or wound disruption rates at the 30 day assessment (20.6% vs 17.6%, P = .62), during the postoperative inpatient hospitalization or at the 1-2 week postoperative visit. There were also no differences in the primary outcome when adjusting for obesity class or thickness of the subcuticular layer. Patients in the treatment group had lower rates of uterine exteriorization (54.3% vs 87.3%, P < .001), but there were no differences in all other outcomes.

CONCLUSION

Use of the Alexis retractor in cesarean delivery deliveries did not decrease SSI or wound disruption rates in an obese population. Its use as a retractor should be left to the discretion of the surgeon and clinical circumstances.

摘要

背景

手术部位感染(SSI)是剖宫产术后发病率的重要原因,尤其是在肥胖患者中。减少剖宫产术后 SSI 的方法对肥胖产科患者具有重要影响。

目的

本研究旨在确定 Alexis O 剖宫产牵开器(一种自固式屏障牵开器)是否可降低肥胖患者剖宫产术后 SSI 和伤口破裂的发生率。

研究设计

这是一项肥胖女性(体重指数≥30kg/m²)择期剖宫产的随机对照试验。患者随机分为治疗组(使用 Alexis O 剖宫产牵开器)或对照组(使用常规手持牵开器)。主要结局是术后 30 天内 SSI 或伤口破裂。次要结局包括手术时间、估计失血量、血红蛋白变化、止吐药使用、术后住院时间、住院再入院和其他术后并发症。

结果

共纳入 301 例患者。144 例患者随机分为治疗组,157 例患者分为对照组。两组患者的基线特征和剖宫产指征相似。中位体重指数为 40.1kg/m²。治疗组和对照组在术后 30 天评估的 SSI 或伤口破裂发生率(20.6% vs. 17.6%,P=0.62)、术后住院期间或术后 1-2 周就诊时的主要结局无显著差异。在调整肥胖程度或皮下层厚度后,主要结局也无差异。治疗组患者子宫外置的发生率较低(54.3% vs. 87.3%,P<0.001),但其他结局无差异。

结论

在肥胖人群中,使用 Alexis 牵开器行剖宫产术并不能降低 SSI 或伤口破裂的发生率。其作为牵开器的使用应根据外科医生的判断和临床情况而定。

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