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

Not Applicable

Completed

• Conditions: Urinary Tract Infections

• Registration Number: NCT00203515
• Lead Sponsor: Tyco Healthcare Group

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Primary Completion: 2007-03
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-04
• Last Update Posted: 2008-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Catheter associated urinary tract infection (UTI)

Secondary Outcome Measures

Name	Time	Method
Catheter tolerance
Cost of care

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States