Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
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
1 other identifier
interventional
9,891
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2021
CompletedResults Posted
Study results publicly available
July 3, 2024
CompletedJuly 3, 2024
October 1, 2021
2.6 years
July 26, 2018
October 22, 2021
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Infections Per 1,000 (CAUTI) Days
Incidence Rate for CAUTIs per 1,000 Catheter days
16 months
Secondary Outcomes (1)
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.
Study Arms (1)
ReadyCleanse for IUC
OTHERReadyCleanse 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- any adult patient who requires an IUC to be placed during admission to one of the four study hospitals
You may not qualify if:
- patients \<18 years of age
- patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor \& delivery or postpartum units, and emergency room
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
NorthShore University HealthSystem - Evanston
Evanston, Illinois, 60201, United States
NorthShore University HealthSystem - Glenbrook
Glenview, Illinois, 60026, United States
NorthShore University HealthSystem - Highland Park
Highland Park, Illinois, 60035, United States
NorthShore University HealthSystem - Skokie
Skokie, Illinois, 60076, United States
Results Point of Contact
- Title
- Keri Jorgenson
- Organization
- Medline Industries, LP
Study Officials
- PRINCIPAL INVESTIGATOR
Kamal S Singh, MD
Endeavor Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2018
First Posted
August 24, 2018
Study Start
August 1, 2018
Primary Completion
February 26, 2021
Study Completion
February 26, 2021
Last Updated
July 3, 2024
Results First Posted
July 3, 2024
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share