Bacterial Colonization After Tunneling in Femoral Perineural Catheters
NCT ID: NCT01016925
Last Updated: 2012-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
338 participants
INTERVENTIONAL
2009-12-31
2011-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control
No interventions assigned to this group
femoral tunnelized perineural catheter
tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.
Interventions
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tunnelized perineural catheter
the catheter will be tunneled 2-3 cm subcutaneously.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Local nerve pathology
* Refusal to regional anaesthesia
* Major psychological disorder
* Major cardiac conduction disease
* Infection at the puncture site
18 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2008/065/HP
Identifier Type: -
Identifier Source: org_study_id
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