Monitoring of Bone Free Flaps With Microdialysis (MTM)
Primary Purpose
Microsurgery, Head and Neck Reconstructive Surgery, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CMA 70 catheter directly positioned in bone tissue
Sponsored by
About this trial
This is an interventional diagnostic trial for Microsurgery focused on measuring microdialysis, bone free flap, head and neck, monitoring free flap, reconstructive surgery
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
Sites / Locations
- Amiens University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microdialysis with CMA 70 catheter
Arm Description
CMA 70 catheter directly positioned in bone tissue
Outcomes
Primary Outcome Measures
Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Secondary Outcome Measures
Evaluation of "flush-out" period
Time required to acquire interpretable data after opening microdialysis circuit
Compliance of the prescription
Compliance rate of simples collected and analysed
Full Information
NCT ID
NCT01879384
First Posted
June 13, 2013
Last Updated
August 9, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Regional Council Picardie
1. Study Identification
Unique Protocol Identification Number
NCT01879384
Brief Title
Monitoring of Bone Free Flaps With Microdialysis
Acronym
MTM
Official Title
Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Regional Council Picardie
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microdialysis with CMA 70 catheter
Arm Type
Experimental
Arm Description
CMA 70 catheter directly positioned in bone tissue
Intervention Type
Device
Intervention Name(s)
CMA 70 catheter directly positioned in bone tissue
Intervention Description
At the end of the surgery the CMA microdialysis catheter is placed inside the bone
Primary Outcome Measure Information:
Title
Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)
Description
Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.
Time Frame
Day 5 after catheter insertion
Secondary Outcome Measure Information:
Title
Evaluation of "flush-out" period
Description
Time required to acquire interpretable data after opening microdialysis circuit
Time Frame
Day 5 after catheter insertion
Title
Compliance of the prescription
Description
Compliance rate of simples collected and analysed
Time Frame
Day 5 after catheter insertion
Other Pre-specified Outcome Measures:
Title
Delay of ischemia detection with metabolic parameters, compared to clinical symptoms
Description
Time between the occurrence of the first metabolic changes and the first clinical signs of tissue damage
Time Frame
from implantation time day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard DEVAUCHELLE, MD, phD
Organizational Affiliation
Amiens University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19155107
Citation
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Citation
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Monitoring of Bone Free Flaps With Microdialysis
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