Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

This study has been completed.

First Received: September 12, 2005 Last Updated: January 4, 2008 History of Changes

Sponsored by:	Tyco Healthcare Group
Information provided by:	Tyco Healthcare Group
ClinicalTrials.gov Identifier:	NCT00203515

Purpose

The purpose of the study is to determine if the commercially available device called the DOVER™ Silver Foley catheter prevents infections of the urinary tract.

Condition	Intervention
Urinary Tract Infections	Device: Standard Latex Foley Catheter Device: Silver Coated Latex Foley Catheter

MedlinePlus related topics: Urinary Tract Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:

Catheter associated urinary tract infection (UTI)

Secondary Outcome Measures:

Catheter tolerance
Cost of care

Estimated Enrollment:	1000
Study Start Date:	January 2005
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Over 1 million catheter-associated urinary tract infections (CAUTIs) occur annually in U.S. healthcare facilities and account for approximately 40% of the nosocomial infections. This investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (Tyco Healthcare DOVER Silver Foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is at least 18 years of age.
Subject is expected to be catheterized with a 14, 16 or 18 French Foley catheter for at least 72 hours.
Subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation.

Exclusion Criteria:

Subjects who present with ongoing, active, symptomatic UTI.
Subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
Subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis.
Subjects known to be pregnant.
Prisoners.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203515

Locations

United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705

Sponsors and Collaborators

Tyco Healthcare Group

Investigators

Study Director:

Bethany A Quinn

Tyco Healthcare Group/Kendall

More Information

Publications:

Tambyah PA, Maki DG. The relationship between pyuria and infection in patients with indwelling urinary catheters: a prospective study of 761 patients. Arch Intern Med. 2000 Mar 13;160(5):673-7.

Study ID Numbers:	302.18
Study First Received:	September 12, 2005
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00203515 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Tyco Healthcare Group:

Urinary Catheterization

Study placed in the following topic categories:

Urologic Diseases
Urinary Tract Infections

Additional relevant MeSH terms:

Urologic Diseases
Urinary Tract Infections
Infection

ClinicalTrials.gov processed this record on May 07, 2009