Monitoring of the 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 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.

Detailed Description
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Failure rate of facial reconstructive surgery with bone free flaps varies between 11 and 25%. In case of buried bone free flaps, the follow up is even more difficult. Monitoring methods, such as the implantable Doppler system, laser Doppler flowmetry and microdialysis have been developped in the last 15 years. Ferguson et al. show a false positive rate of 31% with implantable doppler monitoring of buried flaps. The purpose of this study is to to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Official Title
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Monitoring of the Bone Free Flaps With Microdialysis

Conditions
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Flap Necrosis

Intervention / Treatment
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* Biological: glucose measurement
* Biological: lactacte measurement
* Biological: pyruvate measurement
* Biological: glycerol measurement
* Procedure: Bone free flap monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult person signed informed consent head and neck reconstruction with iliac crest or fibula free flap patient covered by national health insurance Exclusion Criteria: minor person head and neck reconstruction with other types of free flaps than crest or fibula free flap pregnant or breastfeeding women

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: glucose 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.|
|Biological: lactacte 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.|
|Biological: pyruvate 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.|
|Biological: glycerol 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.|
|Procedure: Bone free flap monitoring|Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | every hour during the day of surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | every 2 hours at day 1 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia | every 3 hours at days 2, 3 , 4 and 5 after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | every hour during the day of surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | every 2 hours at day 1 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia | every 3 hours at days 2, 3 , 4 and 5 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | every hour during the day of surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | every 2 hours at day 1 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia | every 3 hours at days 2, 3 , 4 and 5 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia | every hour during the day of surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia | every 2 hours at day 1 after surgery | 
| Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia | Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia | every 3 hours at days 2, 3 , 4 and 5 after surgery | 
| Change from Baseline of metabolites rate in patients with free flap ischemia | Metabolites measurement are glucose, lactate , pyruvate and glycerol rates. | every hour during the day of surgery | 
| Change from Baseline of metabolites rate in patients with free flap ischemia | Metabolites measurement are glucose, lactate , pyruvate and glycerol rates. | every 2 hours at day 1 after surgery | 
| Change from Baseline of metabolites rate in patients with free flap ischemia | Metabolites measurement are glucose, lactate , pyruvate and glycerol rates. | every 3 hours at days 2, 3 , 4 and 5 after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microdialysis, bone free flap, fibula, iliac crest