Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements
NCT ID: NCT01445990
Last Updated: 2011-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2010-01-31
2011-09-30
Brief Summary
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These measures are done after surgical reconstructions with free tissue flap, simultaneously with clinical examination. These biological data aren't available to make clinical diagnosis of complication; only clinical examination is allowed in this way.
A posteriori, clinical and biological parameters will be compared in order to determine if capillary glycaemia and lactataemia measurements is a good procedure for free tissue flaps monitoring.
Detailed Description
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Clinical monitoring remains the most useful and used monitoring method, but makes late and unreliable diagnosis. Numerous studies are searching for ideal monitoring technics with regard to free flaps. Nowadays, the most efficient ones often deal with expensive and invasive technics. In this study, capillary lactataemia and glycaemia measurements are evaluated for pedicle impairments diagnosis.
Measurements of these 2 biological parameters seem to be a powerful screening test of pedicle impairments in microdialysis. But these parameters are measured in this case in interstitial tissues. Capillary measurements will probably provide different results, and needs to be evaluated.
For that purpose, surgical reconstructions with free tissue flap will be clinically monitored during five days, every hours for the first 24 hours, and every 4 hours for the next 4 days. Simultaneously, blind measurements of capillary lactataemia and glycaemia will be performed. Biological and clinical data will be systematically written in the corresponding table of the individual register together with the time the examination is done.
In this register, all complications and evolutions of the flaps will be recorded.
A posteriori, parallel between clinical and biological events will be studied. This multicenter prospective study will show first if capillary measurements of glucose and lactate permit to screen pedicle complications of free flaps. In case of efficacy of this technique, thresholds of glucose and lactate permitting such diagnoses will be calculated in order to define a sensitive screening test. Moreover, temporal differences between clinical and biological diagnoses of pedicle impairments will be studied.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Interventions
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Lactate-meter: LactatePro (ARKRAY Inc)
Capillary glucose and lactate measurement. Every hours for the first 24 hours, and every 4 hours for the next 4 days.
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Free tissue flap reconstruction
* Accessible flap for measurements
Exclusion Criteria
* Patient under 18
* Unaccessible flap
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Centre Hospitalier Universitaire, Amiens
OTHER
Narcisse Zwetyenga
OTHER
Responsible Party
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Narcisse Zwetyenga
Head of Maxillo-Facial, Plastic and Reconstructive Surgery Unit
Principal Investigators
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Benoit Henault, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Dijon
Narcisse Zwetyenga, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Dijon
Julien Pauchot, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire Dijon
Raphaël Sinna, MD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire, Amiens
Christophe Meyer, PhD
Role: STUDY_CHAIR
Centre Hospitalier Universitaire, Besançon
Locations
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Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
Amiens, , France
Maxillo-Facial Surgery, Besancon Univestitary Hospital
Besançon, , France
Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
Besançon, , France
Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire
Dijon, , France
Countries
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Other Identifiers
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2009-A01262-55
Identifier Type: -
Identifier Source: org_study_id