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

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Latex Foley Catheter
Silver Coated Latex Foley Catheter
Sponsored by
Tyco Healthcare Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring Urinary Catheterization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin Hospital and Clinics

Outcomes

Primary Outcome Measures

Catheter associated urinary tract infection (UTI)

Secondary Outcome Measures

Catheter tolerance
Cost of care

Full Information

First Posted
September 12, 2005
Last Updated
January 4, 2008
Sponsor
Tyco Healthcare Group
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1. Study Identification

Unique Protocol Identification Number
NCT00203515
Brief Title
Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tyco Healthcare Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Urinary Catheterization

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Standard Latex Foley Catheter
Intervention Type
Device
Intervention Name(s)
Silver Coated Latex Foley Catheter
Primary Outcome Measure Information:
Title
Catheter associated urinary tract infection (UTI)
Secondary Outcome Measure Information:
Title
Catheter tolerance
Title
Cost of care

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany A Quinn
Organizational Affiliation
Tyco Healthcare Group/Kendall
Official's Role
Study Director
Facility Information:
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10724053
Citation
Tambyah PA, Maki DG. The relationship between pyuria and infection in patients with indwelling urinary catheters: a prospective study of 761 patients. Arch Intern Med. 2000 Mar 13;160(5):673-7. doi: 10.1001/archinte.160.5.673.
Results Reference
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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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