Bacterial Colonization After Tunneling in Femoral Perineural Catheters (Tunnelized KT)
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
|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|
- incidence of femoral perineural catheter colonization [ Time Frame: between 24 hours and 72 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
|No Intervention: Control|
|Experimental: femoral tunnelized perineural catheter||
Procedure: tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016925
|Rouen University Hospital|
|Rouen, France, 76031|