Background: Severe complex facial injuries are difficult to reconstruct and require multiple surgical procedures. The potential of performing complex craniofacial reconstruction in one surgical procedure is appealing, and composite face allograft transplantation may be considered an alternative option. The authors describe establishment of the Cleveland Clinic face transplantation program that led them to perform the first U.S. near-total face transplantation. Methods: In November of 2004, the authors received the world's first institutional review board approval to perform a face transplant in humans. In December of 2008, after a 22-hour operation, the authors performed the first near-total face transplantation in the United States, replacing 80 percent of the patient's traumatic facial deficit with a composite allograft from a brain-dead donor. This largest, and most complex, face allograft in the world included over 535 cm of facial skin; functional units of full nose with nasal lining and bony skeleton; lower eyelids and upper lip; underlying muscles and bones, including orbital floor, zygoma, maxilla, alveolus with teeth, hard palate, and parotid glands; and pertinent nerves, arteries, and veins. Immunosuppressive treatment consisted of thymoglobulin, tacrolimus, mycophenolate mofetil, and prednisone. Results: The patient tolerated the procedure and immunosuppression well. At day 47 after transplantation, routine biopsy showed rejection of the graft mucosa without clinical evidence of skin or graft rejection. The patient's physical and psychological recovery went well. The functional outcome has been excellent, including optimal return of breathing through the nose, smelling, tasting, speaking, drinking from a cup, and eating solid foods. Conclusion: The functional outcome thus far at 8 months is rewarding and confirms the feasibility of performing complex reconstruction of severely disfigured patients in a single surgical procedure of facial allotransplantation.
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