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Sponsored by: |
Tyco Healthcare Group |
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Information provided by: | Tyco Healthcare Group |
ClinicalTrials.gov Identifier: | NCT00203515 |
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 |
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Urinary Tract Infections |
Device: Standard Latex Foley Catheter Device: Silver Coated Latex Foley Catheter |
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 |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2005 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin Hospital and Clinics | |
Madison, Wisconsin, United States, 53705 |
Study Director: | Bethany A Quinn | Tyco Healthcare Group/Kendall |
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 |
Urinary Catheterization |
Urologic Diseases Urinary Tract Infections |
Urologic Diseases Urinary Tract Infections Infection |