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

Not Applicable

Completed

• Conditions: Urinary Tract Infection
• Interventions: Device: Bactiguard Infection Protection (BIP) Cathter.; Device: Silicone Urinary Catheter

• Registration Number: NCT01054690
• Lead Sponsor: Region Skane

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-01
• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-20
• Last Update Submitted: 2010-01-20
• Study First Posted: 2010-01-22
• Last Update Posted: 2010-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver alloyed urinary catheter	Bactiguard Infection Protection (BIP) Cathter.	-
Silicone urinary catheter	Silicone Urinary Catheter	-

Primary Outcome Measures

Name	Time	Method
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.	At catheter withdrawal (normally 1-3 days after catheter insertion).

Secondary Outcome Measures

Name	Time	Method
Patient´s evaluation of the catheterization and overall satisfaction.	At catheter withdrawal and 7-10 days after catheter withdrawal.

Trial Locations

Locations (3)

Ortopedkliniken, Hässleholms Sjukhus; 🇸🇪 Hässleholm, Sweden

Ortopedklinien, Lunds Hospital; 🇸🇪 Lund, Sweden

Ortopedkliniken Lasarettet i Trelleborg; 🇸🇪 Trelleborg, Sweden