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

Region Skane

Status: Completed

Conditions: Urinary Tract Infection

Treatments: Device: Silicone Urinary Catheter; Device: Bactiguard Infection Protection (BIP) Cathter.

Study type: Interventional

Funder types: Other

Identifiers

NCT01054690

H15 315/2007

Details and patient eligibility

About

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).

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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511 participants in 2 patient groups, including a placebo group

Silver alloyed urinary catheter

Experimental group

Treatment:

Device: Bactiguard Infection Protection (BIP) Cathter.

Silicone urinary catheter

Placebo Comparator group

Treatment:

Device: Silicone Urinary Catheter