Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)
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
1 other identifier
interventional
511
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2008
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 14, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedJanuary 22, 2010
January 1, 2010
10 months
January 14, 2010
January 20, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
At catheter withdrawal (normally 1-3 days after catheter insertion).
Secondary Outcomes (1)
Patient´s evaluation of the catheterization and overall satisfaction.
At catheter withdrawal and 7-10 days after catheter withdrawal.
Study Arms (2)
Silver alloyed urinary catheter
EXPERIMENTALSilicone urinary catheter
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adults in elective surgery requiring urinary catheterization
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
- Bactiguard AB, Swedencollaborator
Study Sites (3)
Ortopedkliniken, Hässleholms Sjukhus
Hässleholm, 281 25, Sweden
Ortopedklinien, Lunds Hospital
Lund, 221 85, Sweden
Ortopedkliniken Lasarettet i Trelleborg
Trelleborg, 231 52, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Stenzelius, PhD Nurse
Department Urology, University Hospital in Lund, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 14, 2010
First Posted
January 22, 2010
Study Start
October 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
January 22, 2010
Record last verified: 2010-01