Monitoring of Bone Free Flaps With Microdialysis

Not Applicable

Completed

• Conditions: Head and Neck Cancer; Head and/or Neck Shotgun Trauma; Bone Free Flap; Microsurgery; Head and Neck Reconstructive Surgery
• Interventions: Device: CMA 70 catheter directly positioned in bone tissue

• Registration Number: NCT01879384
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Microdialysis with CMA 70 catheter	CMA 70 catheter directly positioned in bone tissue	CMA 70 catheter directly positioned in bone tissue

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, Picardie, France