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

Catheter-Associated Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03645967
• Other study ID #: R17-019
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: February 26, 2021

Study information

• Verified date: October 2021
• Source: Medline Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9872
• Est. completion date: February 26, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Associated Urinary Tract Infection
• Infections
• Urinary Tract Infections

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem - Evanston	Evanston	Illinois
United States	NorthShore University HealthSystem - Glenbrook	Glenview	Illinois
United States	NorthShore University HealthSystem - Highland Park	Highland Park	Illinois
United States	NorthShore University HealthSystem - Skokie	Skokie	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CAUTI Rates	Infection rate/1000 catheter days based on days of use.	16 months
Secondary	HCP Feedback	Healthcare provider feedback survey will be delivered to all staff that have utilized the ReadyCleanse cloths for indwelling urinary catheter care and maintenance. Purpose of the survey is to investigate healthcare provider preference and opinion of device.	Begins 3 months after start date through completion of study, up to 16 months after study start