Clinical trial NCT01879384: Monitoring of Bone Free Flaps With Microdialysis
Official title: Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microsurgery
Head and Neck Reconstructive Surgery
Head and Neck Cancer
Head and/or Neck Shotgun Trauma
Bone Free Flap
Keywords: microdialysis
bone free flap
head and neck
monitoring free flap
reconstructive surgery
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Regional Council Picardie
First posted: 2013-06-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
timeFrame: Day 5 after catheter insertion
Secondary outcomes:
measure: Evaluation of "flush-out" period
timeFrame: Day 5 after catheter insertion
measure: Compliance of the prescription
timeFrame: Day 5 after catheter insertion
Other outcomes:
measure: Delay of ischemia detection with metabolic parameters, compared to clinical symptoms
timeFrame: from implantation time day 5
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
state: Picardie
Study officials:
affiliation: Amiens University Hospital
name: Bernard DEVAUCHELLE, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
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