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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).

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Detailed Description

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Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Silver alloyed urinary catheter

Group Type EXPERIMENTAL

Bactiguard Infection Protection (BIP) Cathter.

Intervention Type DEVICE

Silicone urinary catheter

Group Type PLACEBO_COMPARATOR

Silicone Urinary Catheter

Intervention Type DEVICE

Interventions

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Bactiguard Infection Protection (BIP) Cathter.

Intervention Type DEVICE

Silicone Urinary Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults in elective surgery requiring urinary catheterization

Exclusion Criteria

* Patients who has or recently (within 3 weeks) had a urinary catheter
* Signs of urinary tracts infection
* Previous radiation therapy in lower pelvis
* Latex allergy
* Cognitive impaired
* Do not understand Swedish language.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No