Monitoring of the Bone Free Flaps With Microdialysis
ConditionFlap Necrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
adult person
signed informed consent
head and neck reconstruction with iliac crest or fibula free flap
patient covered by national health insurance
Disqualifiers
minor person
head and neck reconstruction with other types of free flaps than crest or fibula free flap
pregnant or breastfeeding women
Trial design
Design model
Single group
Treatments tested in this trial
glucose measurement
Biological/VaccineGlucose 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.
lactacte measurement
Biological/VaccineLactate 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.
pyruvate measurement
Biological/Vaccinepyruvate 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.
glycerol measurement
Biological/Vaccineglycerol 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.
Bone free flap monitoring
Procedure/SurgeryBone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
every hour during the day of surgery2
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
Time frame
every 2 hours at day 1 after surgery3
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
Time frame
every 3 hours at days 2, 3 , 4 and 5 after surgerySecondary outcomes
1
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
Time frame
every hour during the day of surgery2
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
Time frame
every 2 hours at day 1 after surgery3
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
Time frame
every 3 hours at days 2, 3 , 4 and 5 after surgery4
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
Time frame
every hour during the day of surgerySponsors and contacts
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Source ClinicalTrials.gov