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Bacterial Colonization After Tunneling in Femoral Perineural Catheters (Tunnelized KT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01016925
First received: November 19, 2009
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.

Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.

Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).

Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling


Condition Intervention
Bacterial Colonization
Procedure: tunnelized perineural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • incidence of femoral perineural catheter colonization [ Time Frame: between 24 hours and 72 hours ] [ Designated as safety issue: Yes ]

Enrollment: 338
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: femoral tunnelized perineural catheter Procedure: tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter

Exclusion Criteria:

  • Age under 18 years
  • Local nerve pathology
  • Refusal to regional anaesthesia
  • Major psychological disorder
  • Major cardiac conduction disease
  • Infection at the puncture site
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016925

Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01016925     History of Changes
Other Study ID Numbers: 2008/065/HP
Study First Received: November 19, 2009
Last Updated: June 22, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by University Hospital, Rouen:
femoral perineural catheter
tunnelization
complication
colonization
infection

ClinicalTrials.gov processed this record on November 20, 2014