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Clinical Trials/NCT00203515
NCT00203515CompletedNot Applicable

A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

Tyco Healthcare Group1 site in 1 country1,000 target enrollmentStarted: January 1, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Locations
1
Primary Endpoint
Catheter associated urinary tract infection (UTI)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Catheter associated urinary tract infection (UTI)

Secondary Outcomes

  • Catheter tolerance
  • Cost of care

Investigators

Sponsor Class
Industry

Study Sites (1)

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