2%葡萄糖酸氯己定沐浴与常规护理预防胰腺手术后手术部位感染:一项单中心随机对照试验

IF 8.5 1区 医学 Q1 INFECTIOUS DISEASES Clinical Microbiology and Infection Pub Date : 2025-05-01 Epub Date: 2025-01-11 DOI:10.1016/j.cmi.2025.01.004
Wen-Sen Chen , Jian-Zhen Lin , Kai Zhang , Xiao-Ping Fang , Rong Wang , Qing-Mei Sun , Hui-Ping Yu , Xu Feng , Zhan-Jie Li , Yue Yang , Qing-Tang Zhu , Feng Zang , Kui-Rong Jiang , Gui-Hua Zhuang
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引用次数: 0

摘要

目的:探讨2%葡萄糖酸氯己定(CHG)沐浴是否能降低常规胰腺手术患者手术部位感染(SSI)的发生率。方法:于2021年1月1日至2022年12月31日在一个大容量胰腺中心进行了一项随机对照试验。接受清洁污染胰腺手术的患者被纳入并随机分为干预组(用2% CHG擦拭沐浴)和对照组(常规护理,肥皂和水)。主要终点是胰腺手术后30天内SSI的发生率。结果:总共614例患者(干预组311例;303例(对照组)纳入意向治疗(ITT)分析。8.8%(54/614)患者发生SSI。干预组SSI发生率为6.8%(21/311),对照组为10.9%(33/303),差异无统计学意义(p=0.070)。干预组患者到SSI的时间显著延长(log-rank检验,p= 0.047)。干预并没有显著降低医疗保健相关感染、医院获得性肺炎和血液感染的发生率。未观察到不良事件。然而,在519例患者的Per-Protocol (PP)分析中,干预组的总体SSI发生率明显低于对照组(21/272,7.7% vs. 33/242, 13.4%, p=0.036)。结论:2%葡萄糖酸氯己定沐浴可以潜在地降低计划接受胰腺手术的患者SSI的发生率,这需要进一步精心设计的临床试验。
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Bathing with 2% chlorhexidine gluconate versus routine care for preventing surgical site infections after pancreatic surgery: a single-centre randomized controlled trial

Objectives

The study aims to investigate whether bathing with 2% chlorhexidine gluconate (CHG) reduces the incidence of surgical site infection (SSI) in patients undergoing routine pancreatic surgery.

Methods

A randomized controlled trial was conducted at a large-volume pancreatic centre between 1 January 2021 and 31 December 2022. Patients undergoing clean-contaminated pancreatic surgery were enrolled and randomized into an intervention arm (bathing with a 2% CHG wipe) and a control arm (routine care, soap, and water). The primary outcome was the incidence of SSI after pancreatic surgery within 30 days.

Results

Overall, 614 patients (intervention arm, 311; control arm, 303) were included in intention-to-treat analysis. In total, 8.8% (54/614) patients developed SSI. The incidence of SSI in the intervention arm was 6.8% (21/311) and 10.9% (33/303) in control arm, and the difference did not reach the level of statistical significance (p 0.070). The time to SSI was significantly extended when patients were in the intervention arm (log-rank test, p 0.047). The intervention did not significantly reduce the incidence of healthcare-associated infection, hospital-acquired pneumonia, and bloodstream infection. No adverse events were observed. However, in the per-protocol analysis among 519 patients, the intervention arm showed a significantly lower incidence of overall SSI than that of those in the control arm (21/272, 7.7% vs. 33/242, 13.4%, p 0.036).

Discussion

Bathing with 2% CHG could potentially reduce the incidence of SSI for the patients scheduled to undergo pancreatic surgery for which further well-designed clinical trials are warranted.
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来源期刊
CiteScore
25.30
自引率
2.10%
发文量
441
审稿时长
2-4 weeks
期刊介绍: Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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