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

This study has been completed.
Sponsor:
Information provided by:
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT00203515
First received: September 12, 2005
Last updated: January 4, 2008
Last verified: January 2008
  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.


Condition Intervention
Urinary Tract Infections
Device: Standard Latex Foley Catheter
Device: Silver Coated Latex Foley Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Tyco Healthcare Group:

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

Secondary Outcome Measures:
  • Catheter tolerance
  • Cost of care

Estimated Enrollment: 1000
Study Start Date: January 2005
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00203515     History of Changes
Other Study ID Numbers: 302.18
Study First Received: September 12, 2005
Last Updated: January 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Tyco Healthcare Group:
Urinary Catheterization

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014