NCT01016925

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

November 19, 2009

Last Update Submit

June 22, 2012

Conditions

Bacterial Colonization

Keywords

femoral perineural cathetertunnelizationcomplicationcolonizationinfection

Outcome Measures

Primary Outcomes (1)

  • incidence of femoral perineural catheter colonization

    between 24 hours and 72 hours

Study Arms (2)

Control

NO INTERVENTION

femoral tunnelized perineural catheter

EXPERIMENTAL
Procedure: tunnelized perineural catheter

Interventions

tunnelized perineural catheterPROCEDURE

the catheter will be tunneled 2-3 cm subcutaneously.

femoral tunnelized perineural catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter

You may not qualify if:

  • Age under 18 years
  • Local nerve pathology
  • Refusal to regional anaesthesia
  • Major psychological disorder
  • Major cardiac conduction disease
  • Infection at the puncture site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

FR(1)