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BIP Foley in Prevention of CAUTI at Rehab Station

NCT02808000 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Complications; Catheter, Urinary Infection or Inflammation

Interventions

DEVICE

BIP Foley (latex) or BIP Foley -silicone

DEVICE

Standard catheter

Sponsors & Collaborators

  • Rehab Station Stockholm

    collaborator UNKNOWN

  • Bactiguard AB

    lead INDUSTRY

Principal Investigators

  • Åke Seiger, MD, Prof · Rehab Station Stockholm and Karolinska Institutet, Stockholm Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-21
Primary Completion
2020-03-09
Completion
2020-03-09

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02808000 on ClinicalTrials.gov