NCT03645967

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9,891 (actual)
• Sponsor: Medline Industries · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Catheter-Associated Urinary Tract Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-08-01
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2018-08-24
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study