Efficacy of a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol for Catheter Care at Reducing CAUTI Rates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03645967|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Catheter-Associated Urinary Tract Infection||Device: ReadyCleanse Cloths||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Intervention in the standard of care for indwelling urinary catheter care and maintenance.|
|Masking:||None (Open Label)|
|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 :||August 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||January 2020|
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.
- CAUTI Rates [ Time Frame: 16 months ]Infection rate/1000 catheter days based on days of use.
- HCP Feedback [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645967
|Contact: Lauren Stanekfirstname.lastname@example.org|
|Contact: Kara Cassadyemail@example.com|
|United States, Illinois|
|NorthShore University HealthSystem - Evanston||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Kamal S Singh, MD 847-733-5093 firstname.lastname@example.org|
|NorthShore University HealthSystem - Glenbrook||Recruiting|
|Glenview, Illinois, United States, 60026|
|Contact: Teo Rafael, MSN, RN 847-657-5852 email@example.com|
|NorthShore University HealthSystem - Highland Park||Recruiting|
|Highland Park, Illinois, United States, 60035|
|Contact: Sara Levin, MSN, RN-BC 847-926-5075 firstname.lastname@example.org|
|NorthShore University HealthSystem - Skokie||Recruiting|
|Skokie, Illinois, United States, 60076|
|Contact: Erika Flechsig, MSN, RN 847-933-6408 email@example.com|
|Principal Investigator:||Kamal S Singh, MD||NorthShore University HealthSystem|