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Trial record 61 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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

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ClinicalTrials.gov Identifier: NCT03645967
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medline Industries

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.

Condition or disease Intervention/treatment Phase
Catheter-Associated Urinary Tract Infection Device: ReadyCleanse Cloths Not Applicable

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.

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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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. CAUTI Rates [ Time Frame: 16 months ]
    Infection rate/1000 catheter days based on days of use.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lauren Stanek 847-643-3145 lstanek@medline.com
Contact: Kara Cassady 847-643-3809 kcassady@medline.com

Locations
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United States, Illinois
NorthShore University HealthSystem - Evanston Recruiting
Evanston, Illinois, United States, 60201
Contact: Kamal S Singh, MD    847-733-5093    ksingh@northshore.org   
NorthShore University HealthSystem - Glenbrook Recruiting
Glenview, Illinois, United States, 60026
Contact: Teo Rafael, MSN, RN    847-657-5852    trafael@northshore.org   
NorthShore University HealthSystem - Highland Park Recruiting
Highland Park, Illinois, United States, 60035
Contact: Sara Levin, MSN, RN-BC    847-926-5075    slevin@northshore.org   
NorthShore University HealthSystem - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Erika Flechsig, MSN, RN    847-933-6408    eflechsig@northshore.org   
Sponsors and Collaborators
Medline Industries
Investigators
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Principal Investigator: Kamal S Singh, MD NorthShore University HealthSystem

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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT03645967     History of Changes
Other Study ID Numbers: R17-019
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases