Severe Facial Deformity — Face Transplantation for Treatment of Severe Facial Deformity
Citation(s)
Aflaki P, Nelson C, Balas B, Pomahac B Simulated central face transplantation: age consideration in matching donors and recipients. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):e283-5. doi: 10.1016/j.bjps.2009.08.013. Epub 2009 Sep 13.
Edrich T, Pomahac B, Lu JT, Couper GS, Gerner P Perioperative management of partial face transplantation involving a heparin antibody-positive donor. J Clin Anesth. 2011 Jun;23(4):318-21. doi: 10.1016/j.jclinane.2010.07.004.
Pomahac B, Aflaki P, Nelson C, Balas B Evaluation of appearance transfer and persistence in central face transplantation: a computer simulation analysis. J Plast Reconstr Aesthet Surg. 2010 May;63(5):733-8. doi: 10.1016/j.bjps.2009.01.078. Epub 2009 Apr 23.
Pomahac B, Aflaki P Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10. pii: e58.
Pomahac B, Bueno EM, Sisk GC, Pribaz JJ Current principles of facial allotransplantation: the Brigham and Women's Hospital Experience. Plast Reconstr Surg. 2013 May;131(5):1069-1076. doi: 10.1097/PRS.0b013e3182865cd3.
Saavedra AP, Bueno EM, Granter SR, Pomahac B Transmission of donor-specific skin condition from donor to recipient of facial allograft. Am J Transplant. 2011 Jun;11(6):1340. doi: 10.1111/j.1600-6143.2011.03596.x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.