择期剖宫产术前预防感染研究（STRIPES）：洗必泰随机临床试验

Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine.

机构信息

Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.

出版信息

Am J Obstet Gynecol. 2020 Jul;223(1):113.e1-113.e11. doi: 10.1016/j.ajog.2020.05.021. Epub 2020 May 12.

DOI:10.1016/j.ajog.2020.05.021

PMID:32407786

Abstract

BACKGROUND

Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora.

OBJECTIVE

To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo.

STUDY DESIGN

In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck, shoulders and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep incisional with or without organ space endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery.

RESULTS

From April 2015 to August 2019, 1356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. A total of 14 patients were lost to follow-up before cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.24). There were no differences in secondary outcomes at 2 or 6 weeks and no differences in primary outcome in a per-protocol analysis.

CONCLUSION

Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.

摘要

背景

剖宫产术后的手术部位感染是产妇发病率的一个原因，通常是由皮肤微生物菌群引起的。在剖宫产前一天晚上和手术当天早上使用氯己定葡萄糖浸渍的布进行预敷，可能会通过减少微生物菌群的丰度来降低手术部位感染的风险。

目的

确定与安慰剂相比，在计划行剖宫产的前一天晚上和手术当天早上使用氯己定葡萄糖布擦拭 6 个身体部位（颈部、肩部和胸部、腋窝、手臂和手部、腹部和腹股沟、左腿和脚、右腿和脚、背部和臀部）是否能降低术后 6 周内手术部位感染的风险。

研究设计

在这项单中心、双盲、安慰剂对照试验中，患者按 1:1 的比例随机（随机）分配到接受 Sage 2%氯己定布或 Sage Comfort Bath 无香料布（安慰剂）擦拭 6 个身体部位（颈部、肩部和胸部、腋窝、手臂和手部、腹部和腹股沟、左腿和脚、右腿和脚、背部和臀部）的组中。在计划行剖宫产的前一天晚上和手术当天早上沐浴后。常规临床和手术程序均遵循。主要结局是术后 6 周内的手术部位感染（浅层或深层切口，伴有或不伴有器官间隙子宫内膜炎）。次要结局是术后 2 周和 6 周时的手术部位感染和其他与伤口相关的并发症。

结果

2015 年 4 月至 2019 年 8 月，共纳入 1356 例患者：682 例分配至氯己定组，674 例分配至安慰剂组。两组在人口统计学和医疗特征方面相似。共有 14 例患者在剖宫产前失访（氯己定组 10 例，安慰剂组 4 例），33 例患者在剖宫产后失访（氯己定组 10 例，安慰剂组 23 例）。在其余 1309 例（97%）患者中，两组术后 6 周的手术部位感染率无差异（氯己定组 2.6%，安慰剂组 3.7%；P=.24）。在 2 周和 6 周时的次要结局无差异，且在符合方案分析中主要结局无差异。