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

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ClinicalTrials.gov Identifier: NCT01445990
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : October 6, 2011
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire, Amiens
Information provided by (Responsible Party):
Narcisse Zwetyenga, Centre Hospitalier Universitaire Dijon

September 30, 2011
October 4, 2011
October 6, 2011
January 2010
September 2011   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01445990 on ClinicalTrials.gov Archive Site
  • 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.

  • 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.

Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Postoperative Complications
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
Same as current
September 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Patient under 18
  • Unaccessible flap
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01445990
2009-A01262-55
Yes
Not Provided
Not Provided
Narcisse Zwetyenga, Centre Hospitalier Universitaire Dijon
Narcisse Zwetyenga
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire, Amiens
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
Centre Hospitalier Universitaire Dijon
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP