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
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 |
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).
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Ortopedkliniken, Hässleholms Sjukhus | Hässleholm | |
Sweden | Ortopedklinien, Lunds Hospital | Lund | |
Sweden | Ortopedkliniken Lasarettet i Trelleborg | Trelleborg |
Lead Sponsor | Collaborator |
---|---|
Region Skane | Bactiguard AB, Sweden |
Sweden,
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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