Status:
COMPLETED
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
Lead Sponsor:
Tyco Healthcare Group
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00203515
Start Date
January 1 2005
Last Update
January 14 2008
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705