Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates

NCT ID: NCT03645967

Last Updated: 2024-07-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9891 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2021-02-26

Brief Summary

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

Detailed Description

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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.

Conditions

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Catheter-Associated Urinary Tract Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention in the standard of care for indwelling urinary catheter care and maintenance.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ReadyCleanse for IUC

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.

Group Type OTHER

ReadyCleanse Cloths

Intervention Type DEVICE

ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.

Interventions

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ReadyCleanse Cloths

ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kamal S Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Locations

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NorthShore University HealthSystem - Evanston

Evanston, Illinois, United States

Site Status

NorthShore University HealthSystem - Glenbrook

Glenview, Illinois, United States

Site Status

NorthShore University HealthSystem - Highland Park

Highland Park, Illinois, United States

Site Status

NorthShore University HealthSystem - Skokie

Skokie, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R17-019

Identifier Type: -

Identifier Source: org_study_id

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