The primary objective of this study is to evaluate the 5-year (60-month) allograft survival rate of facial vascularized composite allotransplantation performed under the standardized CONSORT clinical protocol.
Competent to provide informed consent, as determined through structured clinical assessment by qualified study personnel, and able to demonstrate adequate psychosocial support, including caregiver or other support-person assistance as needed, to facilitate postoperative recovery, adherence to immunosuppressive therapy, and long-term study follow-up.
Non smoker at the time of transplantation (no cigarettes, vaping, or nicotine products), with counseling and support offered for cessation as needed.
Negative pregnancy test at listing and again immediately prior to transplant.
Agreement to use effective contraception throughout study participation and for at least 12 months post transplant.
Anatomical or surgical factors that render transplantation unsafe or technically unfeasible (e.g., prohibitive vascular disease, prior surgeries precluding adequate anastomoses) in the judgment of the surgical team.
Positive Human Immunodeficiency Virus (HIV) serology (unless future evidence and institutional policy support inclusion under tightly controlled conditions).
Active or inadequately treated serious infection, including tuberculosis, hepatitis B or C with uncontrolled viremia, or syphilis.
Active malignancy.
Single group
Facial Vascularized Composite Allotransplantation (VCA)
Procedure/SurgeryFacial VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices.
Number of participants with Allograft Survival at 60 months
Allograft survival is defined as the continued presence of the transplanted facial tissue with evidence of adequate vascular perfusion assessed as clinical evaluation by the surgical team. Survival is a binary categorical variable (Success/Failure). Failure is defined as total graft loss necessitating surgical removal (explantation).
Number of participants with Motor Function Change
Number of participants with improvement in motor function change. Assessed using a clinical grading in mild, moderate, severe for every facial muscle.
Number of participants with Sensory Restoration
Number of participants with Sensory Restoration. Quantified by Static Two-Point Discrimination (2PD) measured in millimeters (mm) across the V2 (maxillary) and V3 (mandibular) distributions. A decrease in the minimum distance perceived as two distinct points indicates nerve regeneration and improved tactile acuity.
Mean score General Health Status (PROMIS-29 v2.0)
29-item questionnaire that measures general physical, mental, and social health-related quality of life. Results are converted into T-scores where 50 is the average for the U.S. general population, with a standard deviation of 10. Higher score means worse symptoms or better ability.
Mean score Health Utility (EQ-5D-5L)
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life. It consists of consists of 5 dimensions each scored: 1= no problems, 2= slight problems, 3=moderate problems, 4= severe problems, and 5= extreme problems. Higher scores indicated greater levels of problems across each of the five dimensions.
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Yale University
Lead sponsor
Wake Forest University Health Sciences
Collaborator
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