Bacterial Colonization After Tunneling in Femoral Perineural Catheters

NCT ID: NCT01016925

Last Updated: 2012-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Colonization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

femoral tunnelized perineural catheter

Group Type EXPERIMENTAL

tunnelized perineural catheter

Intervention Type PROCEDURE

the catheter will be tunneled 2-3 cm subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tunnelized perineural catheter

the catheter will be tunneled 2-3 cm subcutaneously.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rouen University Hospital

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008/065/HP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Powdered Intrawound Vancomycin in Open Fractures Trial
NCT06504992 NOT_YET_RECRUITING PHASE4
Antiseptic Use and Dressing Application
NCT00389558 COMPLETED PHASE4