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

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ClinicalTrials.gov Identifier: NCT00203515
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 14, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Device: Standard Latex Foley Catheter Device: Silver Coated Latex Foley Catheter Not Applicable

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 Type : Interventional  (Clinical Trial)
Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
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
Study Start Date : January 2005
Actual Primary Completion Date : March 2007

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Primary Outcome Measures :
  1. Catheter associated urinary tract infection (UTI)

Secondary Outcome Measures :
  1. Catheter tolerance
  2. Cost of care


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00203515


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Tyco Healthcare Group
Investigators
Study Director: Bethany A Quinn Tyco Healthcare Group/Kendall

Publications:
ClinicalTrials.gov Identifier: NCT00203515     History of Changes
Other Study ID Numbers: 302.18
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: January 14, 2008
Last Verified: January 2008

Keywords provided by Tyco Healthcare Group:
Urinary Catheterization

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases