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

Urinary Tract Infection Clinical Trial

Official title:

A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054690
• Other study ID #: H15 315/2007
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

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