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Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue


N/A
18 Years
N/A
Open (Enrolling)
Both
Microsurgery, Head and Neck Reconstructive Surgery, Head and Neck Cancer, Head and/or Neck Shotgun Trauma, Bone Free Flap

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Trial Information

Feasibility of Monitoring of Bone Free Flaps With Microdialysis Catheter Directly Positioned in Bone Tissue


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Feasibility study of monitoring bone free flaps with microdialysis (catheter directly positioned in bone tissue)

Outcome Description:

Success of microdialysis is defined as the collection and measurement of metabolites levels as: lactate, pyruvate,glycerol and glucose.

Outcome Time Frame:

Day 5 after catheter insertion

Safety Issue:

No

Principal Investigator

Bernard DEVAUCHELLE, MD, phD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Amiens University Hospital

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

PI08-PR-DEVAUCHELLE

NCT ID:

NCT01879384

Start Date:

February 2011

Completion Date:

December 2013

Related Keywords:

  • Microsurgery
  • Head and Neck Reconstructive Surgery
  • Head and Neck Cancer
  • Head and/or Neck Shotgun Trauma
  • Bone Free Flap
  • microdialysis
  • bone free flap
  • head and neck
  • monitoring free flap
  • reconstructive surgery
  • Head and Neck Neoplasms

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