Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Bacterial Colonization Clinical Trial

— Tunnelized KT  

Official title:

Bacterial Colonization After Tunneling in Femoral Perineural Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016925
• Other study ID #: 2008/065/HP
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: June 22, 2012
• Start date: December 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Colonization

Intervention

Procedure:
• tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of femoral perineural catheter colonization		between 24 hours and 72 hours	Yes