An interventional study of CMA 70 catheter directly positioned in bone tissue in Microsurgery, Head and Neck Reconstructive Surgery and Head and Neck Cancer, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Diagnostic
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
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 :
Data are managed with Labpilot software.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 34 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: Day 5 after catheter insertion
Evaluation of "flush-out" period
Time required to acquire interpretable data after opening microdialysis circuit
Time frame: Day 5 after catheter insertion
Compliance of the prescription
Compliance rate of simples collected and analysed
Time frame: Day 5 after catheter insertion
Delay of ischemia detection with metabolic parameters, compared to clinical symptoms
Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage
Time frame: from implantation time day 5
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens