RecruitingNot ApplicableNCT03935139

Monitoring of the Bone Free Flaps With Microdialysis


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

40 participants

Start Date

Jul 22, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. The aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

When surgeons reconstruct parts of the head and neck after cancer surgery or trauma, they often use "free flaps" — pieces of bone and tissue taken from another part of the body (such as the fibula in the leg or the iliac crest in the hip). Monitoring whether this transplanted tissue stays alive and healthy is critical in the days after surgery. This study examines whether a technique called microdialysis — which measures chemical changes in the tissue — can reliably detect early signs that the flap is failing. Early detection of flap complications can make the difference between saving and losing the transplanted tissue, and ultimately between a successful reconstruction and a devastating setback for the patient. You may be eligible if: - You are an adult (18 or older) - You are undergoing head and neck reconstruction using an iliac crest or fibula free flap - You are covered by national health insurance - You have signed informed consent You may NOT be eligible if: - You are a minor (under 18) - You are having head and neck reconstruction with a different type of free flap - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALglucose measurement

Glucose values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.

BIOLOGICALlactacte measurement

Lactate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.

BIOLOGICALpyruvate measurement

pyruvate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.

BIOLOGICALglycerol measurement

glycerol values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.

PROCEDUREBone free flap monitoring

Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.


Locations(1)

CHU Amiens

Amiens, France

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NCT03935139


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