Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01054690
Enrollment
511
Registered
2010-01-22
Start date
2008-10-31
Completion date
2009-08-31
Last updated
2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection

Keywords

Catheterization, Urinary Tract Infection, Elective Surgery

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).

Interventions

DEVICEBactiguard Infection Protection (BIP) Cathter.
DEVICESilicone Urinary Catheter

Sponsors

Bactiguard AB, Sweden
CollaboratorUNKNOWN
Region Skane
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Patient´s evaluation of the catheterization and overall satisfaction.At catheter withdrawal and 7-10 days after catheter withdrawal.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026