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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters

NCT02915692

Surgery

TERMINATED

Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

NCT01054690

Urinary Tract Infection

COMPLETED NA

Randomized Study of Silq Urinary Catheter

NCT04841226

Biofilm Formation UTI

COMPLETED NA

A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter

NCT02119351

Peripheral Intravenous Catheter

COMPLETED NA

Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections

NCT00318591

Urinary Tract Infections

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Urinary Tract Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard Latex Foley Catheter

Intervention Type DEVICE

Silver Coated Latex Foley Catheter

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No