Back to resultsMonitoring of the Bone Free Flaps With Microdialysis (MTM2018)
Primary Purpose
Flap Necrosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
glucose measurement
lactacte measurement
pyruvate measurement
glycerol measurement
Bone free flap monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Flap Necrosis focused on measuring microdialysis, bone free flap, fibula, iliac crest
Eligibility Criteria
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
Sites / Locations
- CHU AmiensRecruiting
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
Change from Baseline of metabolites rate in patients with free flap ischemia
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Change from Baseline of metabolites rate in patients with free flap ischemia
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Change from Baseline of metabolites rate in patients with free flap ischemia
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Full Information
NCT ID
NCT03935139
First Posted
April 30, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03935139
Brief Title
Monitoring of the Bone Free Flaps With Microdialysis
Acronym
MTM2018
Official Title
Monitoring of the Bone Free Flaps With Microdialysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flap Necrosis
Keywords
microdialysis, bone free flap, fibula, iliac crest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
glucose measurement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
lactacte measurement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
pyruvate measurement
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
glycerol measurement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bone free flap monitoring
Intervention Description
Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.
Primary Outcome Measure Information:
Title
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
Time Frame
every hour during the day of surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
Time Frame
every 2 hours at day 1 after surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia
Description
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
Secondary Outcome Measure Information:
Title
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
Time Frame
every hour during the day of surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
Time Frame
every 2 hours at day 1 after surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without fibula free flap ischemia
Description
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
Title
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
Time Frame
every hour during the day of surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
Time Frame
every 2 hours at day 1 after surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients without crest free flap ischemia
Description
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
Title
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
Time Frame
every hour during the day of surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia
Time Frame
every 2 hours at day 1 after surgery
Title
Change from Baseline of lactate/pyruvate ratio in patients with free flap ischemia
Description
Change from Baseline of lactate/pyruvate ratio in patients with crest free flap ischemia
Time Frame
every 3 hours at days 2, 3 , 4 and 5 after surgery
Title
Change from Baseline of metabolites rate in patients with free flap ischemia
Description
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Time Frame
every hour during the day of surgery
Title
Change from Baseline of metabolites rate in patients with free flap ischemia
Description
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Time Frame
every 2 hours at day 1 after surgery
Title
Change from Baseline of metabolites rate in patients with free flap ischemia
Description
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Time Frame
every 3 hours at days 2, 3 , 4 and 5 after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Dakpe, MD
Phone
(33)322089050
Email
dakpe.stephanie@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie Testelin, Pr
Phone
(33)322089050
Email
testelin.sylvie@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Dakpe, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Dakpe, MD
Phone
(33)322089050
Email
dakpe.stephanie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Sylvie Testelin, Pr
Phone
(33)322089050
Email
testelin.sylvie@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Monitoring of the Bone Free Flaps With Microdialysis
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