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生理盐水与 Savlon 溶液用于尿道周围清洁以减少导尿管相关性菌尿的效果比较:一项随机对照试验。

A comparison of the efficacy of normal saline and Savlon solutions in periurethral cleaning to reduce catheter-associated bacteriuria: A randomized control trial.

机构信息

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

出版信息

Int J Infect Dis. 2021 Apr;105:702-708. doi: 10.1016/j.ijid.2021.02.086. Epub 2021 Feb 23.

Abstract

OBJECTIVE

Catheter-associated urinary tract infection (CAUTI) is a common nosocomial infection. However, there has been no randomized control trial (RCT) comparing the efficacy of periurethral cleaning solutions for reducing CAUTI. This study aimed to compare the efficacy of normal saline solution (NSS) and Savlon solution.

METHODS

A non-inferiority cross-over RCT was conducted to compare the 2 solutions by the incidence of significant bacteriuria (SB) on day 5 after Foley catheterization. Patients admitted to a tertiary referral hospital from June 2018 to August 2019 participated in the study. The acceptable prespecified non-inferiority margin was 10%.

RESULTS

There were 265 and 275 patients in the NSS and Savlon groups, respectively. The incidence of CAUTI was 2.65/1000 catheter-days, and the median duration of catheterization was 5 days (IQR 4, 7). There was no significant difference between the incidence of SB in the NSS and Savlon groups, as indicated by the adjusted difference of 0.6 (95% CI: -3.1-4.2).

CONCLUSION

This study was the first RCT in patients from multiple hospital units to compare the efficacy of the 2 solutions in the periurethral cleaning process. The study demonstrated non-inferiority of NSS to Savlon solution.

THAI CLINICAL TRIALS REGISTRY STUDY ID

TCTR20180518001.

摘要

目的

导管相关尿路感染(CAUTI)是一种常见的医院获得性感染。然而,目前还没有随机对照试验(RCT)比较不同尿道周围清洁溶液预防 CAUTI 的效果。本研究旨在比较生理盐水溶液(NSS)和 Savlon 溶液的疗效。

方法

采用非劣效性交叉 RCT 比较 2 种溶液在 Foley 导尿管插入后第 5 天显著菌尿(SB)的发生率。2018 年 6 月至 2019 年 8 月期间,三级转诊医院的患者参与了这项研究。可接受的预设非劣效性边界为 10%。

结果

NSS 组和 Savlon 组分别有 265 例和 275 例患者。CAUTI 的发生率为 2.65/1000 导管日,中位导管插入时间为 5 天(IQR 4, 7)。NSS 和 Savlon 组的 SB 发生率无显著差异,调整后的差异为 0.6(95%CI:-3.1-4.2)。

结论

这是首次在来自多个医院科室的患者中进行的 RCT,比较了 2 种溶液在尿道周围清洁过程中的疗效。研究表明 NSS 与 Savlon 溶液等效。

泰国临床试验注册研究 ID:TCTR20180518001。

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