Monitoring of the Bone Free Flaps With Microdialysis (MTM2018)

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.

Study Overview

• Status: Recruiting
• Conditions: Flap Necrosis
• Intervention / Treatment: Biological: glucose measurement; Biological: lactacte measurement; Biological: pyruvate measurement; Biological: glycerol measurement; Procedure: Bone free flap monitoring

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie Dakpe, MD; Phone Number: (33)322089050; Email: dakpe.stephanie@chu-amiens.fr
• Study Contact Backup: Name: Sylvie Testelin, Pr; Phone Number: (33)322089050; Email: testelin.sylvie@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80480
    • Recruiting
    • CHU Amiens
    • Contact: Stéphanie Dakpe, MD; Phone Number: (33)322089050; Email: dakpe.stephanie@chu-amiens.fr
    • Contact: Sylvie Testelin, Pr; Phone Number: (33)322089050; Email: testelin.sylvie@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	every hour during the day of surgery
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	every 2 hours at day 1 after surgery
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia	every hour during the day of 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 fibula free flap ischemia	every 2 hours at day 1 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 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 crest free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	every hour during the day of surgery
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia	every 2 hours at day 1 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 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 with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	every hour during the day of surgery
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia	every 2 hours at day 1 after surgery
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia	Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia	every 3 hours at days 2, 3 , 4 and 5 after surgery
Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every hour during the day of surgery
Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every 2 hours at day 1 after surgery
Change from Baseline of metabolites rate in patients with free flap ischemia	Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.	every 3 hours at days 2, 3 , 4 and 5 after surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 30, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: microdialysis; bone free flap; fibula; iliac crest
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: PI2018_843_0023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No