Efficacy Study of Free Flap Monitoring Using Capillary Lactate and Glucose Measurements

Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications
• Intervention / Treatment: Device: Lactate-meter: LactatePro (ARKRAY Inc)

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
  • Besancon, France, 25000
    • Maxillo-Facial Surgery, Besancon Univestitary Hospital
  • Besancon, France, 25000
    • Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
  • Dijon, France, 21000
    • Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy
• Patient under 18
• Unaccessible flap

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical examination of the flap	Clinical examination is done immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis). Then, examinations are done every hours for the first 24 hours, and every 4 hours for the next 4 days. The clinical examination was standardized: skin paddle colour and temperature, skin reperfusion time, and bleeding test with a prick. In order to avoid bias, examinations are performed by caregivers before capillary lactate and glucose measurements, and they hadn't any information about expected results of lactate and glucose values.	Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Capillary lactate measurements	Capillary lactate is measured immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis). Then, measurements are done every hours for the first 24 hours, and every 4 hours for the next 4 days. In order to avoid bias, measurements are performed by caregivers after clinical examination, and they hadn't any information about expected results of lactate and glucose values.	Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose measurements and clinical examinations.
Capillary glucose measurements	Capillary glucose is measured immediately after the end of the surgical procedure (Expected 1 to 5 hours after the end of arterial anastomosis). Then, measurements are done every hours for the first 24 hours, and every 4 hours for the next 4 days. In order to avoid bias, measurements are performed by caregivers after clinical examination, and they hadn't any information about expected results of lactate and glucose values.	Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations.

Collaborators and Investigators

• Sponsor: Narcisse Zwetyenga
• Collaborators: Centre Hospitalier Universitaire, Amiens; Centre Hospitalier Universitaire de Besancon
• Investigators: Study Chair: Benoit Henault, MD, Centre Hospitalier Universitaire Dijon; Principal Investigator: Narcisse Zwetyenga, PhD, Centre Hospitalier Universitaire Dijon; Study Chair: Julien Pauchot, MD, Centre Hospitalier Universitaire Dijon; Study Chair: Raphaël Sinna, MD, Centre Hospitalier Universitaire, Amiens; Study Chair: Christophe Meyer, PhD, Centre Hospitalier Universitaire, Besançon

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: October 3, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: diagnostic test; thrombosis; glucose; free tissue flaps; lactic acid; Pedicle postoperative complications diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 2009-A01262-55