Clinical trial NCT03935139: Monitoring of the Bone Free Flaps With Microdialysis
Official title: Monitoring of the Bone Free Flaps With Microdialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flap Necrosis
Keywords: microdialysis
bone free flap
fibula
iliac crest
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
timeFrame: every hour during the day of surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
timeFrame: every 2 hours at day 1 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
timeFrame: every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary outcomes:
measure: Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
timeFrame: every hour during the day of surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
timeFrame: every 2 hours at day 1 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
timeFrame: every 3 hours at days 2, 3 , 4 and 5 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
timeFrame: every hour during the day of surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
timeFrame: every 2 hours at day 1 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
timeFrame: every 3 hours at days 2, 3 , 4 and 5 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
timeFrame: every hour during the day of surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
timeFrame: every 2 hours at day 1 after surgery
measure: Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
timeFrame: every 3 hours at days 2, 3 , 4 and 5 after surgery
measure: Change from Baseline of metabolites rate in patients with free flap ischemia
timeFrame: every hour during the day of surgery
measure: Change from Baseline of metabolites rate in patients with free flap ischemia
timeFrame: every 2 hours at day 1 after surgery
measure: Change from Baseline of metabolites rate in patients with free flap ischemia
timeFrame: every 3 hours at days 2, 3 , 4 and 5 after surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Stéphanie Dakpe, MD
role: PRINCIPAL_INVESTIGATOR
References: