Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)

NCT00555282 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2010-02-05

No results posted yet for this study

Summary

The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Conditions

  • Bacteriaemia
  • Catheter Related Bloodstream Infection

Interventions

DEVICE

central venous catheter

coated central venous catheter

DEVICE

central venous catheter

standard central venous catheter

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Jan Pachl, Prof. Dr. · Faculty Hospital Charles University Prague

  • Pavel Sevcik, Prof. Dr. · Brno University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Czechia

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 NCT00555282 on ClinicalTrials.gov