Monitoring of the Bone Free Flaps With Microdialysis (MTM2018)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Flap Necrosis

Treatments: Biological: glycerol measurement; Procedure: Bone free flap monitoring; Biological: lactacte measurement; Biological: glucose measurement; Biological: pyruvate measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT03935139

PI2018_843_0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)