Expired Study
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Madison, Wisconsin 53705


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.


Study summary:

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.


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.


NCT ID:

NCT00203515


Primary Contact:

Study Director
Bethany A Quinn
Tyco Healthcare Group/Kendall


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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