Back to results

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

Primary Purpose

Catheter-Associated Urinary Tract Infection

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ReadyCleanse Cloths

About this trial

This is an interventional prevention trial for Catheter-Associated Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

NorthShore University HealthSystem - Evanston
NorthShore University HealthSystem - Glenbrook
NorthShore University HealthSystem - Highland Park
NorthShore University HealthSystem - Skokie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ReadyCleanse for IUC

Arm Description

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.

Outcomes

Primary Outcome Measures

CAUTI Rates

Infection rate/1000 catheter days based on days of use.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03645967

First Posted

July 26, 2018

Last Updated

October 13, 2021

Sponsor

Medline Industries

1. Study Identification

Unique Protocol Identification Number

NCT03645967

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

February 26, 2021 (Actual)

Study Completion Date

February 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medline Industries

4. Oversight

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

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter-Associated Urinary Tract Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

9872 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ReadyCleanse for IUC

Arm Type

Other

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

ReadyCleanse Cloths

Intervention Description

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.

Primary Outcome Measure Information:

Title

CAUTI Rates

Description

Infection rate/1000 catheter days based on days of use.

Time Frame

16 months

Secondary Outcome Measure Information:

Title

HCP Feedback

Description

Time Frame

Begins 3 months after start date through completion of study, up to 16 months after study start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kamal S Singh, MD

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

Facility Information:

Facility Name

NorthShore University HealthSystem - Evanston

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

NorthShore University HealthSystem - Glenbrook

City

Glenview

State/Province

Illinois

ZIP/Postal Code

60026

Country

United States

Facility Name

NorthShore University HealthSystem - Highland Park

City

Highland Park

State/Province

Illinois

ZIP/Postal Code

60035

Country

United States

Facility Name

NorthShore University HealthSystem - Skokie

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs