Bone Free Flap, Head and Neck Cancer, Head and Neck Reconstructive Surgery, Head and/or Neck Shotgun Trauma, Microsurgery
Conditions
Keywords
microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery
Brief 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.
Interventions
DEVICECMA 70 catheter directly positioned in bone tissue
At the end of the surgery the CMA microdialysis catheter is placed inside the bone
Sponsors
Regional Council Picardie
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue) | Day 5 after catheter insertion | Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of flush-out period | Day 5 after catheter insertion | Time required to acquire interpretable data after opening microdialysis circuit |
| Compliance of the prescription | Day 5 after catheter insertion | Compliance rate of simples collected and analysed |
Other
| Measure | Time frame | Description |
|---|---|---|
| Delay of ischemia detection with metabolic parameters, compared to clinical symptoms | from implantation time day 5 | Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage |
Countries
France
Outcome results
None listed