An interventional study of glucose measurement and lactacte measurement in Flap Necrosis, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Treatment
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.
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.
90 studies on the registry are indexed under Necrosis; 23 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 53 interventional studies indexed under Necrosis.
Browse Necrosis studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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 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 flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.
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 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 fibula free flap ischemia
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
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
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
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
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
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
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
Change from Baseline of lactate/pyruvate ratio in patients with crest 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
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
Change from Baseline of metabolites rate in patients with free flap ischemia
Metabolites measurement are glucose, lactate , pyruvate and glycerol rates.
Time frame: 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.
Time frame: 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.
Time frame: every 3 hours at days 2, 3 , 4 and 5 after surgery
Plan to share: No
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