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OpenTrials
Completed

NCT Number: NCT01879384

Monitoring of Bone Free Flaps With Microdialysis

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

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Key information

Conditions

Microsurgery Bone Free Flap Head and Neck Cancer Head and Neck Neoplasms Head and Neck Reconstructive Surgery Head and/or Neck Shotgun Trauma Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMA 70 catheter directly positioned in bone tissue

Device

At the end of the surgery the CMA microdialysis catheter is placed inside the bone

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluation of "flush-out" period

    Time frame: Day 5 after catheter insertion

    Time required to acquire interpretable data after opening microdialysis circuit

  2. Compliance of the prescription

    Time frame: Day 5 after catheter insertion

    Compliance rate of simples collected and analysed

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Regional Council Picardie

Registry information

Official study title

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

Acronym: MTM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2013
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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