search
Back to results

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

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bactiguard Infection Protection (BIP) Cathter.
Silicone Urinary Catheter
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring Catheterization, Urinary Tract Infection, Elective Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ortopedkliniken, Hässleholms Sjukhus
  • Ortopedklinien, Lunds Hospital
  • Ortopedkliniken Lasarettet i Trelleborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silver alloyed urinary catheter

Silicone urinary catheter

Arm Description

Outcomes

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.

Secondary Outcome Measures

Patient´s evaluation of the catheterization and overall satisfaction.

Full Information

First Posted
January 14, 2010
Last Updated
January 20, 2010
Sponsor
Region Skane
Collaborators
Bactiguard AB, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT01054690
Brief Title
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Region Skane
Collaborators
Bactiguard AB, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Catheterization, Urinary Tract Infection, Elective Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silver alloyed urinary catheter
Arm Type
Experimental
Arm Title
Silicone urinary catheter
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Bactiguard Infection Protection (BIP) Cathter.
Intervention Type
Device
Intervention Name(s)
Silicone Urinary Catheter
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Patient´s evaluation of the catheterization and overall satisfaction.
Time Frame
At catheter withdrawal and 7-10 days after catheter withdrawal.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Stenzelius, PhD Nurse
Organizational Affiliation
Department Urology, University Hospital in Lund, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ortopedkliniken, Hässleholms Sjukhus
City
Hässleholm
ZIP/Postal Code
281 25
Country
Sweden
Facility Name
Ortopedklinien, Lunds Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Ortopedkliniken Lasarettet i Trelleborg
City
Trelleborg
ZIP/Postal Code
231 52
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs