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

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445990
• Other study ID #: 2009-A01262-55
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: October 5, 2011
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed patient

• Signed informed consent

• Free tissue flap reconstruction

• Accessible flap for measurements

Exclusion Criteria:

• Pregnancy

• Patient under 18

• Unaccessible flap

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
France	Department of Plastic reconstructive and Aesthetic Surgery. University Hospital Amiens	Amiens
France	Maxillo-Facial Surgery, Besancon Univestitary Hospital	Besancon
France	Orthopaedic, Traumatologic and Plastic Surgery Unit, Besancon Universitary Hospital	Besancon
France	Maxillo-Facial, Plastic and Reconstructive Surgery Unit, Centre Hospitalier Universitaire	Dijon

Sponsors (3)

Lead Sponsor	Collaborator
Narcisse Zwetyenga	Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No