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

This study has been completed.
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire, Amiens
Information provided by (Responsible Party):
Narcisse Zwetyenga, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01445990
First received: September 30, 2011
Last updated: October 5, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Postoperative Complications
Device: Lactate-meter: LactatePro (ARKRAY Inc)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Diagnostic
Official Title: Evaluation of Free Tissue Flaps Viability With Capillary Glucose and Lactate Measurements Compared With Clinical Examination

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Clinical examination of the flap [ Time Frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose and lactate measurements. ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Capillary lactate measurements [ Time Frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary glucose measurements and clinical examinations. ] [ Designated as safety issue: No ]

    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.


  • Capillary glucose measurements [ Time Frame: Beginning immediately after free flap surgical procedure. Realized 48 times during the 5 first postoperative days. Synchronous with capillary lactate measurements and clinical examinations. ] [ Designated as safety issue: No ]

    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.



Enrollment: 31
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: 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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Patient under 18
  • Unaccessible flap
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445990

Locations
France
Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
Amiens, France, 80000
Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
Besancon, France, 25000
Maxillo-Facial Surgery, Besancon Univestitary Hospital
Besancon, France, 25000
Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire
Dijon, France, 21000
Sponsors and Collaborators
Narcisse Zwetyenga
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire, Amiens
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
  More Information

No publications provided

Responsible Party: Narcisse Zwetyenga, Head of Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01445990     History of Changes
Other Study ID Numbers: 2009-A01262-55
Study First Received: September 30, 2011
Last Updated: October 5, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire Dijon:
free tissue flaps
lactic acid
glucose
thrombosis
diagnostic test
Pedicle postoperative complications diagnosis

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014