Yale University
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.
The study population includes adults (18+) with severe facial disfigurement meeting the following criteria: * Anatomic Severity: Loss of total facial surface area or absence of a critical central unit (e.g., nose or lips). * Refractory Status: Defects not reconstructible via conventional autologous surgical techniques. * Impairment: Significant deficits in essential functions (speech, swallowing, breathing, eyelid closure).
Inclusion Criteria: Participants: * 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. * For participants of reproductive potential: * Negativ…
Facial VCA, performed to treat severe facial defects. This procedure will be performed by qualified surgeons in accordance with standard institutional surgical practices.