NCT00203515

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

A Prospective, Randomized, Controlled Study Comparing the DOVER Silver Foley Catheter to a Standard of Care Catheter and a Marketed Silver Coated Foley Catheter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (planned)
• Sponsor: Tyco Healthcare Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DEVICE	Standard Latex Foley Catheter
DEVICE	Silver Coated Latex Foley Catheter

Timeline

• Start date: 2005-01-01
• Primary completion: 2007-03-01
• First posted: 2005-09-20
• Last updated: 2008-01-14

Locations

1 site across 1 country: United States