Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Outcomes of face transplantation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
- •The facial defect cannot be restored with traditional reconstruction techniques.
- •Signed written informed consent.
- •Willing to complete psychological and social evaluations.
- •Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
- •Willing to return for follow-up visits as determined by the treating physician and to comply with extensive post-transplant rehabilitation therapy.
- •Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.
排除标准
- •Active malignancy.
- •High risk of return of malignancy.
- •History of persistent non-compliance.
- •Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
- •Any diagnosis that puts the subject at risk during the face transplant surgery.
- •Absence of adequate donor sites for skin grafting in the event of transplant failure.
结局指标
主要结局
Outcomes of face transplantation.
时间窗: Subjects will be followed for 18 months after face transplantation
We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
次要结局
- Procedural outcomes of face transplantation(From subject recruitment to 18 months after transplantation)
- Functional outcomes of face transplantation(Subjects will be followed for 18 months following face transplantation)
- Financial and economic aspects of face transplantation(Subjects will be followed for 18 months after face transplantation)
- Efficacy and optimization of the immune suppression protocol.(18 months)
- Psychosocial outcomes of face transplantation(Subjects will be followed up for 18 months following face transplantation)
研究者
Bodhan Pomahac
Medical Director, Burn Center
Brigham and Women's Hospital
