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NCT Number: NCT03935139

Monitoring of the Bone Free Flaps With Microdialysis

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.

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Key information

Conditions

Flap Necrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glucose measurement

Biological

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.

lactacte measurement

Biological

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.

pyruvate measurement

Biological

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.

glycerol measurement

Biological

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.

Bone free flap monitoring

Procedure

Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.

Primary outcomes

  1. Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia

    Time frame: every hour during the day of surgery

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

  2. Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia

    Time frame: every 2 hours at day 1 after surgery

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

  3. 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 surgery

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

Secondary outcomes

  1. Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

    Time frame: every hour during the day of surgery

    Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

  2. Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

    Time frame: every 2 hours at day 1 after surgery

    Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

  3. 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 surgery

    Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia

  4. Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

    Time frame: every hour during the day of surgery

    Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

  5. Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

    Time frame: every 2 hours at day 1 after surgery

    Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

  6. Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia

    Time frame: 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

  7. Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia

    Time frame: every hour during the day of surgery

    Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia

  8. Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia

    Time frame: every 2 hours at day 1 after surgery

    Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia

  9. Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia

    Time frame: 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

  10. Change from Baseline of metabolites rate in patients with free flap ischemia

    Time frame: every hour during the day of surgery

    Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.

  11. Change from Baseline of metabolites rate in patients with free flap ischemia

    Time frame: every 2 hours at day 1 after surgery

    Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.

  12. Change from Baseline of metabolites rate in patients with free flap ischemia

    Time frame: every 3 hours at days 2, 3 , 4 and 5 after surgery

    Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphanie Dakpe, MD

CONTACT

[email protected]

(33)322089050

Sylvie Testelin, Pr

CONTACT

[email protected]

(33)322089050

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MTM2018

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
May 2, 2019
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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