跳至主要内容
临床试验/NCT03645967
NCT03645967已完成不适用

Efficacy of Meatal and Perineal Care With a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol in Reducing Catheter-Associated Urinary Tract Infections in Acute-Care Hospitals

Medline Industries4 个研究点 分布在 1 个国家目标入组 9,891 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
9,891
试验地点
4
主要终点
Infections Per 1,000 (CAUTI) Days

研究概览

简要总结

Superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.

详细描述

A superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. The primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (IUC) care and maintenance provides a reduction in CAUTIs. The ReadyCleanse complete cleansing system will replace the previous standard-of-care. The ReadyCleanse intervention will be compared to the previous standard-of-care retrospectively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •any adult patient who requires an IUC to be placed during admission to one of the four study hospitals

排除标准

  • •patients <18 years of age
  • •patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor & delivery or postpartum units, and emergency room

研究组 & 干预措施

ReadyCleanse for IUC

Other

ReadyCleanse Cloths will be used for the standard of care for indwelling urinary catheter care and maintenance. The old standard of care will no longer be used.

干预措施: ReadyCleanse Cloths (Device)

结局指标

主要结局

Infections Per 1,000 (CAUTI) Days

时间窗: 16 months

Incidence Rate for CAUTIs per 1,000 Catheter days

次要结局

  • Number of "Health Care Providers Responding to Health Care Provider Feedback Survey(Begins 3 months after start date. Time to take survey is approximately 10 minutes.)

研究者

发起方
Medline Industries
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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