Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: composite tissue allotransplantation.
- Who it may be relevant to
- Registry conditions: Surgery, Oral. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
In hindsight, the first "face graft" raises the fundamental problem of composite tissue allotransplantation (hand, larynx, abdominal wall, etc.) with the addition of specific technical and philosophical problems. By proposing a prospective study concerning five new patients over the next three years, in the light of this first experience, the authors would like to confirm the surgical feasibility of this type of procedure, possibly extending it to other parts of the face (lateral third) and, like English and American teams, considering the possibility of total facial surface reconstruction. In parallel, and while complying with the usual immunosuppression procedures, the deliberate choice of creating a microchimerism by the infusion of bone marrow stem cells (the origin and quantity of which will need to be determined) will be reaffirmed, in order to improve mucocutaneous tissue tolerance, while confirming the safety of this type of approach. Five new cases will also provide observations for the many new fields of research developing around composite tissue transplants (neurophysiology, skin histopathology, psychiatry, haematology, immunology, etc.).
Interventions
- Procedure composite tissue allotransplantation
Primary outcome measures
- functional recovery : motor recovery [Time frame: 1 year]
- functional recovery : sensory recovery [Time frame: 1 year]
- functional recovery : sensory recovery [Time frame: 1 year]
Secondary outcome measures (3)
- functional recovery : motor recovery [Time frame: 2 years, 5 years]
- functional recovery : sensory recovery [Time frame: 2 years, 5 years]
- functional recovery : sensory recovery [Time frame: 2 years, 5 years]
Eligibility criteria
Inclusion criteria
- Patients with loss of unrepairable substance by conventional techniques shreds, at the front
Exclusion criteria
- Facial lesions repaired by conventional reconstructive surgery techniques
- History of malignancy in remission for less than 5 years
- Malignant neoplasm undergoing changes
- Severe psychiatric history
- Patients above a score of 2 on the scale of the ASA (American Society of Anesthesiology)
- Patients above a grade 1 in the classification NYHA ( New York Heart Association )
- insufficient with renal creatinine clearance less than 70 mL / min or presence of a proteinuria
- Severe hypertension
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CHU Amiens — Amiens
Identifiers
NCT: NCT02818400 · PHRCN06-PR-DEVAUCHELLE