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

Urinary Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203515
• Other study ID #: 302.18
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 4, 2008
• Start date: January 2005

Study information

• Verified date: January 2008
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Device:
• Standard Latex Foley Catheter

• Silver Coated Latex Foley Catheter

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter associated urinary tract infection (UTI)
Secondary	Catheter tolerance
Secondary	Cost of care