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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01054690
Other study ID # H15 315/2007
Secondary ID
Status Completed
Phase N/A
First received January 14, 2010
Last updated January 20, 2010
Start date October 2008
Est. completion date August 2009

Study information

Verified date January 2010
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 511
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Device:
Bactiguard Infection Protection (BIP) Cathter.

Silicone Urinary Catheter


Locations

Country Name City State
Sweden Ortopedkliniken, Hässleholms Sjukhus Hässleholm
Sweden Ortopedklinien, Lunds Hospital Lund
Sweden Ortopedkliniken Lasarettet i Trelleborg Trelleborg

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Bactiguard AB, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Yes
Secondary Patient´s evaluation of the catheterization and overall satisfaction. At catheter withdrawal and 7-10 days after catheter withdrawal. Yes
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