Clinical trial NCT01445990: Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements
Official title: Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: free tissue flaps
lactic acid
glucose
thrombosis
diagnostic test
Pedicle postoperative complications diagnosis
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: Centre Hospitalier Universitaire, Amiens
First posted: 2011-10-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of capillary glycaemia and lactataemia measurements for pedicle impairments diagnosis in free tissue transfers is realized.

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: Free tissue flap reconstruction has become a reliable technique. Nevertheless, pedicle thrombosis is dreaded, and the earlier the diagnosis of such complications is made, the higher the surgical salvage rate is.

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.

Eligibility criteria: Inclusion Criteria:

* Informed patient
* Signed informed consent
* Free tissue flap reconstruction
* Accessible flap for measurements

Exclusion Criteria:

* Pregnancy
* Patient under 18
* Unaccessible flap

Primary outcomes:
measure: Clinical examination of the flap
timeFrame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.
Secondary outcomes:
measure: Capillary lactate measurements
timeFrame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose measurements and clinical examinations.
measure: Capillary glucose measurements
timeFrame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
city: Besancon
country: France
facility: Maxillo-Facial Surgery, Besancon Univestitary Hospital
city: Besancon
country: France
facility: Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
city: Dijon
country: France
facility: Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Benoit Henault, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire Dijon
name: Narcisse Zwetyenga, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire Dijon
name: Julien Pauchot, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire, Amiens
name: Raphaël Sinna, MD
role: STUDY_CHAIR
affiliation: Centre Hospitalier Universitaire, Besançon
name: Christophe Meyer, PhD
role: STUDY_CHAIR
References: