Flap NecrosisMTM2018NCT03935139
Monitoring of the Bone Free Flaps With Microdialysis
A study testing glucose measurement, lactacte measurement and pyruvate measurement in people with Flap Necrosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flap Necrosis
- What is being tested?
- glucose measurement, lactacte measurement and pyruvate measurement
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jul 2019to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult person
- signed informed consent
- head and neck reconstruction with iliac crest or fibula free flap
- patient covered by national health insurance
Who cannot join
- minor person
- head and neck reconstruction with other types of free flaps than crest or fibula free flap
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Stéphanie Dakpe, MD, (33)322089050, dakpe.stephanie@chu-amiens.fr
Sylvie Testelin, Pr, (33)322089050, testelin.sylvie@chu-amiens.fr
About this study
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.
Read the 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.
- Conditions
- Flap Necrosis
- Being tested
- glucose measurement, lactacte measurement, pyruvate measurement, glycerol measurement, Bone free flap monitoring
- Keywords
- microdialysis, bone free flap, fibula, iliac crest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose measurementBiological
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 measurementBiological
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 measurementBiological
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 measurementBiological
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 monitoringProcedure or surgery
Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: every 3 hours at days 2, 3 , 4 and 5 after surgery
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: every 3 hours at days 2, 3 , 4 and 5 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start22 Jul 2019
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flap NecrosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Dakpe, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935139
- Sponsor's protocol ID
- PI2018_843_0023
- Acronym
- MTM2018
- Status last verified
- Jul 2024
- First submitted
- 30 Apr 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of the Bone Free Flaps With Microdialysis
- ClinicalTrials.gov ID
- NCT03935139
- Acronym / sponsor ID
- MTM2018 / PI2018_843_0023
- Conditions
- Flap Necrosis
- Keywords
- microdialysis, bone free flap, fibula, iliac crest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult person
- signed informed consent
- head and neck reconstruction with iliac crest or fibula free flap
- patient covered by national health insurance
Key exclusion criteria (3 listed)
- minor person
- head and neck reconstruction with other types of free flaps than crest or fibula free flap
- pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glucose measurementGlucose 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. | Biological | – |
| lactacte measurementLactate 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. | Biological | – |
| pyruvate measurementpyruvate 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. | Biological | – |
| glycerol measurementglycerol 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. | Biological | – |
| Bone free flap monitoringBone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue. | Procedure or surgery | – |
Primary outcome
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
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
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
12 secondary outcomes
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
Time frame: every 2 hours at day 1 after surgery
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 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
Time frame: every 2 hours at day 1 after surgery
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 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
Time frame: every 2 hours at day 1 after surgery
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 metabolites rate in patients with free flap ischemia
Time frame: every hour during the day of surgery
Change from Baseline of metabolites rate in patients with free flap ischemia
Time frame: every 2 hours at day 1 after surgery
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Dakpe, MD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose measurement, lactacte measurement and pyruvate measurement in people with Flap Necrosis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Dakpe, MD ((33)322089050, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of lactate/pyruvate ratio in patients without free flap ischemia (time frame: every hour during the day of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.