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BIP Foley in Prevention of CAUTI at Rehab Station

2016-06-21 19:08:22 | BioPortfolio

Summary

This is a prospective, cross-over, randomized, controlled, partly blinded study evaluating safety and performance of noble metal alloy urinary Catheters (BIP Foley, Bactiguard AB) of both latex and silicone. The included patients are permanently catheterized spinal cord injured patients at the Spinalis clinic at Rehab station in Stockholm, Sweden.

Primary Outcome Measures:

• The primary objective is to evaluate the efficacy of long term suprapubic use of BIP Foley catheters, compared to the use of standard catheters for the same time period, on re-current symptomatic catheter associated urinary tract infection (CAUTIs).

Secondary Outcome Measures:

• to evaluate safety/performance of the catheter, i.e. antibiotic use, bacteriuria, bacteremia, urosepsis and ICU stay.

Exploratory Outcome Measures:

• assessment of levels of immunological markers in urine, urinary bacterial type and resistance pattern, catheter comfort, stability of the coating, and bacterial biofilm on the catheter surface after use.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Conditions

Complications; Catheter, Urinary Infection or Inflammation

Intervention

BIP Foley (latex) or BIP Foley -silicone, Standard catheter

Location

Rehab Station Stockholm
Stockholm
Solna
Sweden
169 89

Status

Recruiting

Source

Bactiguard AB

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-21T19:08:22-0400

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