Monitoring of Bone Free Flaps With Microdialysis
Conditions
Microsurgery - Head and Neck Reconstructive Surgery - Head and Neck Cancer - Head and/or Neck Shotgun Trauma - Bone Free Flap
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: CMA 70 catheter directly positioned in bone tissue
Type: Device
Overall Status
Recruiting
Summary
Microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. Nevertheless, a few authors reported follow up with microdialysis in bone flaps, and they all described the position of the catheter in the surrounding soft tissue muscle. This surrounding soft tissue is not always the reflect of bone vascularisation.

The aim is to study the feasibility of a follow up of microanastomosed bone flaps with microdialysis. To reach this goal, investigators perform a clinical prospective research project untitled MTM project
Detailed Description
In addition to our classical clinical monitoring, bone microanastomosed flaps for reconstructive facial surgery will be monitored with CMA 70 catheter directly positioned in bone tissue.

The monitoring is recorded during 5 days. Glucose, lactate , pyruvate , glycerol rates will be analysed :

- every hour at day 1,

- every two hours at day 2,

- every three hours at day 3,4 and 5.

Data are managed with Labpilot software.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- head and neck reconstruction with iliac crest or fibula free flaps

- informed consent obtained

Exclusion Criteria:

- reconstruction with other types of free flaps
Location
Amiens University Hospital
Amiens, Picardie, France
Status: Recruiting
Contact: Bernard DEVAUCHELLE, MD, phD - 0033 3 22 66 83 25 - devauchelle.bernard@chu-amiens.fr
Start Date
February 2011
Completion Date
December 2013
Sponsors
Centre Hospitalier Universitaire, Amiens
Source
Centre Hospitalier Universitaire, Amiens
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page