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OpenTrials
Completed

NCT Number: NCT01016925

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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Key information

Conditions

Bacterial Colonization Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tunnelized perineural catheter

Procedure

the catheter will be tunneled 2-3 cm subcutaneously.

Primary outcomes

  1. incidence of femoral perineural catheter colonization

    Time frame: between 24 hours and 72 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: Tunnelized KT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 20, 2009
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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