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

Tyco Healthcare Group

Status

Completed

Conditions

Urinary Tract Infections

Treatments

Device: Standard Latex Foley Catheter

Device: Silver Coated Latex Foley Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT00203515

302.18

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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.