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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Catheter-Associated Urinary Tract Infection

Intervention / Treatment
-----------------
* Device: ReadyCleanse Cloths


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention in the standard of care for indwelling urinary catheter care and maintenance.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ReadyCleanse for IUC<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAUTI Rates | Infection rate/1000 catheter days based on days of use. | 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |