Face Transplantation for Treatment of Severe Facial Deformity
Condition: Severe Facial Deformity
MeSH terms: Congenital Abnormalities; Facies
Study type: Interventional

Summary: 
      Face transplantation surgery is the transfer of face tissue from a deceased human donor to a
      patient with a severe facial deformity. Face transplantation is an innovative reconstructive
      procedure that has the potential to significantly improve the lives of patients with severe
      facial injuries. The purpose of this study is to develop the best practices for facial
      transplantation that will improve the outcomes of future face transplant recipients.
    

Detailed description: 
      The United States Department of Defense (DoD) awarded Brigham and Women's Hospital (BWH) a
      research contract to fund 5 face transplantation surgeries.

      The investigators are now actively seeking candidates for the procedure. The primary
      requirements to be considered as a candidate for face transplant surgery are: at least 18
      years old; lost a major part of the face, such as the nose or the lips, or lost at least 25%
      of their facial tissue; and the facial injury cannot be treated acceptably by conventional
      reconstructive surgery. There are number of other factors that the investigators consider to
      determine who would be a suitable candidate.

      From the time the investigators begin our search for a qualified face transplant recipient to
      the continuing care the investigators provide following surgery, a significant amount of
      time, expertise, and attentiveness is contributed toward making the procedure a progressive
      success. Below is an overview of what happens before, during and after a face transplant
      procedure.

      Face transplant candidates go through an extensive screening process that is likely to last
      several months. This screening includes a psychiatric and social support evaluation and a
      series of imaging tests to help determine a patient's physical and mental readiness for the
      procedure. If, upon completion of the screening process, it is determined that a patient is a
      suitable candidate, the investigators will place the patient on a transplant waiting list.
      The investigators will then begin working to find a donor who matches the recipient's tissue
      requirements - e.g., similar age, right blood type. This search could take many months, and,
      if a suitable donor is not found within one year, the investigators will speak with the
      patient to determine whether they're willing to continue waiting. When a donor is found, the
      investigators will immediately inform the patient about when to arrive at the hospital for
      the operation. As the timing for this type of procedure is extremely important, patients are
      expected to be readily available.

      The area most likely to be reconstructed in a face transplant is the central region of the
      face, which includes the nose and lips, as these facial structures are the most difficult to
      reconstruct with conventional plastic surgery techniques. In our most recent case, the face
      transplant included the entire nose; the soft tissues of the mid-face, including all its
      blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton.
      Surgeons will then connect the facial graft blood vessels to the patient's blood vessels
      under a microscope to restore blood circulation before connecting nerves and other tissue,
      such as bone, cartilage and muscles, as needed.

      While the face transplant is taking place, a separate, smaller surgery will also be
      performed. The investigators will take a skin sample (graft) from the arm of the donor and
      then attach the sample to the patient's chest or abdomen. The intent is to have the graft
      behave like the face transplant tissue, eventually becoming part of the patient's own skin.
      This is done so that later the investigators can take tiny samples (biopsies) of the new
      chest/abdomen tissue to look for signs of rejection, thereby minimizing the need to disturb
      the new face tissue after surgery.

      Immediately after surgery, the face transplant recipient will be taken to the Intensive Care
      Unit (ICU) for observation. The patient will typically stay in the ICU for one or two days
      and then be moved to a private room. At this point, a physical therapist will help the
      patient regain as much facial movement as possible, and a psychiatrist will discuss any
      psychological concerns.

      The patient will stay in the hospital until both the plastic surgery and medical transplant
      teams agree that it is safe for the patient to return home. This post-operative stay is
      anticipated to be approximately 7-14 days, but can vary due to a number of factors.

      Following their discharge, face transplant patients will need to return to BWH for routine
      visits. These visits will include monitoring transplant drug levels (immune suppressants)
      through regular blood tests, imaging tests, assessing quality of life and checking for the
      return of sensation and movement to the face. The investigators will also periodically
      examine small tissue samples from the chest/abdomen graft under a microscope to look for any
      signs of rejection. These visits will typically take place on a weekly basis for the first
      three months and then at least once a month for the first year following surgery.

      After the first year, it is expected that face transplant patients will need to visit the
      hospital less and less as time passes. However, patients should be prepared to make a
      lifetime commitment to immune suppressants to help prevent the rejection of the transplanted
      face tissue.
    

Intervention name(s): Facial Allograft Transplantation
Intervention type(s): Procedure
Intervention description(s): Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
Other intervention name(s): face transplantation; facial transplantation; composite facial allograft transplantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: facial transplantation; face transplantation; composite tissue allotransplantation; VCA; composite tissue allograft; facial allograft