Monitoring of the Bone Free Flaps With Microdialysis

Not Applicable

Recruiting

• Conditions: Flap Necrosis

• Registration Number: NCT03935139
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study First Submitted: 2019-04-30
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-07-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia

Secondary Outcome Measures

Name	Time	Method
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 fibula 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 without crest free flap ischemia
Change from Baseline of lactate/pyruvate ratio in patients with 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 crest free flap ischemia
Change from Baseline of metabolites rate in patients with free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France