Monitoring of Bone Free Flaps With Microdialysis (MTM)

September 16, 2025 updated by: Centre Hospitalier Universitaire, Amiens

Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.

The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In addition to our classical clinical monitoring, bone microanastomosed flaps for reconstructive facial surgery will be monitored with CMA 70 catheter directly positioned in bone tissue.

The monitoring is recorded during 5 days. Glucose, lactate , pyruvate , glycerol rates will be analysed :

  • every hour at day 1,
  • every two hours at day 2,
  • every three hours at day 3,4 and 5.

Data are managed with Labpilot software.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Picardie
      • Amiens, Picardie, France, 80054
        • Amiens University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • head and neck reconstruction with iliac crest or fibula free flaps
  • informed consent obtained

Exclusion Criteria:

  • reconstruction with other types of free flaps

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Microdialysis with CMA 70 catheter
CMA 70 catheter directly positioned in bone tissue
Device: CMA 70 catheter directly positioned in bone tissue
At the end of the surgery the CMA microdialysis catheter is placed inside the bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
Time Frame: Day 5 after catheter insertion
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Day 5 after catheter insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of "flush-out" period
Time Frame: Day 5 after catheter insertion
Time required to acquire interpretable data after opening microdialysis circuit
Day 5 after catheter insertion
Compliance of the prescription
Time Frame: Day 5 after catheter insertion
Compliance rate of simples collected and analysed
Day 5 after catheter insertion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delay of ischemia detection with metabolic parameters, compared to clinical symptoms
Time Frame: from implantation time day 5
Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage
from implantation time day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Regional Council Picardie

Investigators

  • Principal Investigator: Bernard DEVAUCHELLE, MD, phD, Amiens University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimated)

June 17, 2013

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI08-PR-DEVAUCHELLE
  • 2010-A01176-33 (Other Identifier: ID-RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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