Monitoring of Bone Free Flaps With Microdialysis (MTM)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Microsurgery; Head and Neck Reconstructive Surgery; Bone Free Flap; Head and Neck Cancer; Head and/or Neck Shotgun Trauma

Treatments: Device: CMA 70 catheter directly positioned in bone tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT01879384

PI08-PR-DEVAUCHELLE

2010-A01176-33 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

34 participants in 1 patient group

Microdialysis with CMA 70 catheter

Experimental group

Description:

CMA 70 catheter directly positioned in bone tissue

Treatment:

Device: CMA 70 catheter directly positioned in bone tissue