RecruitingNot ApplicableNCT03935139

Monitoring of the Bone Free Flaps With Microdialysis


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

40 participants

Start Date

Jul 22, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • adult person
  • signed informed consent
  • head and neck reconstruction with iliac crest or fibula free flap
  • patient covered by national health insurance

Exclusion Criteria3

  • minor person
  • head and neck reconstruction with other types of free flaps than crest or fibula free flap
  • pregnant or breastfeeding women

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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.


Locations(1)

CHU Amiens

Amiens, France

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NCT03935139


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