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

This study has been completed.
Sponsor:
Collaborator:
Bactiguard AB, Sweden
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT01054690
First received: January 14, 2010
Last updated: January 20, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition Intervention
Urinary Tract Infection
 Device: Bactiguard Infection Protection (BIP) Cathter.
Device: Silicone Urinary Catheter

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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. [ Time Frame: At catheter withdrawal (normally 1-3 days after catheter insertion). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient´s evaluation of the catheterization and overall satisfaction. [ Time Frame: At catheter withdrawal and 7-10 days after catheter withdrawal. ] [ Designated as safety issue: Yes ]

Enrollment: 511
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silver alloyed urinary catheter Device: Bactiguard Infection Protection (BIP) Cathter.
Placebo Comparator: Silicone urinary catheter Device: Silicone Urinary Catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054690

Locations
Sweden
Ortopedkliniken, Hässleholms Sjukhus
Hässleholm, Sweden, 281 25
Ortopedklinien, Lunds Hospital
Lund, Sweden, 221 85
Ortopedkliniken Lasarettet i Trelleborg
Trelleborg, Sweden, 231 52
Sponsors and Collaborators
Region Skane
Bactiguard AB, Sweden
Investigators
Principal Investigator: Karin Stenzelius, PhD Nurse Department Urology, University Hospital in Lund, Sweden
  More Information

No publications provided

Responsible Party: Karin Stenzelius, PhD Nurse, Department of Urology, University Hospital in Lund
ClinicalTrials.gov Identifier: NCT01054690     History of Changes
Other Study ID Numbers: H15 315/2007
Study First Received: January 14, 2010
Last Updated: January 20, 2010
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Catheterization
Urinary Tract Infection
Elective Surgery

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013