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

Sponsor

Medline Industries (Industry)

Overall Status

Completed

CT.gov ID

NCT03645967

Collaborator

(none)

9,872

Enrollment

Locations

Arm

30.9

Actual Duration (Months)

2468

Patients Per Site

79.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Catheter-Associated Urinary Tract Infection	Device: ReadyCleanse Cloths	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

9872 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Feb 26, 2021

Actual Study Completion Date :

Feb 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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.

Arm

Intervention/Treatment

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

CAUTI Rates [16 months]
Infection rate/1000 catheter days based on days of use.

Secondary Outcome Measures

HCP Feedback [Begins 3 months after start date through completion of study, up to 16 months after study start]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NorthShore University HealthSystem - Evanston	Evanston	Illinois	United States	60201
2	NorthShore University HealthSystem - Glenbrook	Glenview	Illinois	United States	60026
3	NorthShore University HealthSystem - Highland Park	Highland Park	Illinois	United States	60035
4	NorthShore University HealthSystem - Skokie	Skokie	Illinois	United States	60076

Sponsors and Collaborators

Medline Industries

Investigators

Principal Investigator: Kamal S Singh, MD, NorthShore University HealthSystem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medline Industries

ClinicalTrials.gov Identifier:

NCT03645967

Other Study ID Numbers:

R17-019

First Posted:

Aug 24, 2018

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Infections

Urinary Tract Infections

Study Results

No Results Posted as of Oct 14, 2021