Bacterial Colonization Clinical Trial
Official title:
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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