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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01054690
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : January 22, 2010
Bactiguard AB, Sweden
Information provided by:
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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Silver alloyed urinary catheter Device: Bactiguard Infection Protection (BIP) Cathter.
Placebo Comparator: Silicone urinary catheter Device: Silicone Urinary Catheter

Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. Patient´s evaluation of the catheterization and overall satisfaction. [ Time Frame: At catheter withdrawal and 7-10 days after catheter withdrawal. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01054690

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
Principal Investigator: Karin Stenzelius, PhD Nurse Department Urology, University Hospital in Lund, Sweden

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
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010

Keywords provided by Region Skane:
Urinary Tract Infection
Elective Surgery

Additional relevant MeSH terms:
Communicable Diseases
Urinary Tract Infections
Urologic Diseases