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Completed

NCT Number: NCT00203515

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

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.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Latex Foley Catheter

Device

Silver Coated Latex Foley Catheter

Device

Primary outcomes

  1. Catheter associated urinary tract infection (UTI)

Secondary outcomes

  1. Catheter tolerance

  2. Cost of care

Sponsors and collaborators

Lead sponsor

Tyco Healthcare Group

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
First posted
Sep 20, 2005
Registry last updated
Jan 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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