Flap Necrosis
Conditions
Keywords
microdialysis, bone free flap, fibula, iliac crest
Brief 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.
Detailed description
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.
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.
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 metabolites rate in patients with free flap ischemia | every hour during the day of surgery | Metabolites measurement are glucose, lactate , pyruvate and glycerol rates. |
Countries
France
Contacts
Primary ContactStéphanie Dakpe, MD
Backup ContactSylvie Testelin, Pr
Outcome results
None listed