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

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lactate-meter: LactatePro (ARKRAY Inc)
Sponsored by
Narcisse Zwetyenga
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Complications focused on measuring free tissue flaps, lactic acid, glucose, thrombosis, diagnostic test, Pedicle postoperative complications diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Patient under 18
  • Unaccessible flap

Sites / Locations

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 30, 2011
Last Updated
October 5, 2011
Sponsor
Narcisse Zwetyenga
Collaborators
Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01445990
Brief Title
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

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Narcisse Zwetyenga
Collaborators
Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
free tissue flaps, lactic acid, glucose, thrombosis, diagnostic test, Pedicle postoperative complications diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Lactate-meter: LactatePro (ARKRAY Inc)
Intervention Description
Capillary glucose and lactate measurement. Every hours for the first 24 hours, and every 4 hours for the next 4 days.
Primary Outcome Measure Information:
Title
Clinical examination of the flap
Description
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.
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.
Secondary Outcome Measure Information:
Title
Capillary lactate measurements
Description
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.
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.
Title
Capillary glucose measurements
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Henault, MD
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Narcisse Zwetyenga, PhD
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julien Pauchot, MD
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raphaël Sinna, MD
Organizational Affiliation
Centre Hospitalier Universitaire, Amiens
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christophe Meyer, PhD
Organizational Affiliation
Centre Hospitalier Universitaire, Besançon
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Maxillo-Facial Surgery, Besancon Univestitary Hospital
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire
City
Dijon
ZIP/Postal Code
21000
Country
France

12. IPD Sharing Statement

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

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