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Completed

NCT Number: NCT01445990

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

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.

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Key information

Conditions

Postoperative Complications Cardiovascular Diseases Embolism and Thrombosis Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Patient under 18
  • Unaccessible flap

Treatment and study plan

Lactate-meter: LactatePro (ARKRAY Inc)

Device

Capillary glucose and lactate measurement. Every hours for the first 24 hours, and every 4 hours for the next 4 days.

Primary outcomes

  1. 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.

    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 outcomes

  1. 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.

    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.

  2. 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.

    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.

Sponsors and collaborators

Lead sponsor

Narcisse Zwetyenga

Other

Collaborators

  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire, Amiens

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2011
Registry last updated
Oct 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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