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

November 19, 2009
June 22, 2012
December 2009
December 2011   (final data collection date for primary outcome measure)
incidence of femoral perineural catheter colonization [ Time Frame: between 24 hours and 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01016925 on ClinicalTrials.gov Archive Site
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Bacterial Colonization After Tunneling in Femoral Perineural Catheters
Bacterial Colonization After Tunneling in Femoral Perineural Catheters

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

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Bacterial Colonization
Procedure: tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.
  • No Intervention: Control
  • Experimental: femoral tunnelized perineural catheter
    Intervention: Procedure: tunnelized perineural catheter
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
338
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01016925
2008/065/HP
Not Provided
University Hospital, Rouen
University Hospital, Rouen
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Not Provided
University Hospital, Rouen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP