Monitoring of Bone Free Flaps With Microdialysis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Microsurgery, Head and Neck Reconstructive Surgery, Head and Neck Cancer, Head and/or Neck Shotgun Trauma, Bone Free Flap

Intervention / Treatment
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* Device: CMA 70 catheter directly positioned in bone tissue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue) | 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 required to acquire interpretable data after opening microdialysis circuit | Day 5 after catheter insertion | 
| Compliance of the prescription | Compliance rate of simples collected and analysed | Day 5 after catheter insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery