Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- allograft survival
研究概览
简要总结
Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.
详细描述
Abdominal wall transplantation surgery, the transfer of the abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect, is an experimental reconstructive procedure that has the potential to significantly improve the lives of patients.
In abdominal wall transplantation, the tissues transplanted include skin, tendons, muscles, ligaments, bones and blood vessels. The transplant team at Brigham and Women's Hospital includes a wide variety of medical and surgical specialties.
The team BWH is actively seeking qualified candidates for the abdominal wall transplantation research study. We will be studying a small group of people to learn more about:
- How to advance the science of abdominal wall transplantation
- How to support and limit transplant rejection issues
- How people do after abdominal wall transplantation We describe abdominal wall transplant surgery as a life-giving procedure because it has the potential to dramatically improve, that is to restore, both a patient's mental and physical health and his/her ability to function and integrate in society. However, as with any other type of organ transplantation, this improvement will require the patient to make a lifetime commitment to taking medications that suppress the body's immune system.
Conventional reconstruction methods are always considered first, but they may provide less than optimal results for certain patients. There are other methods available to reconstruct the abdominal wall. However, they may yield unsatisfactory outcomes in some patients. Abdominal wall transplantation surgery, however, has the potential to deliver these desired functional and aesthetic benefits. Functionally, abdominal wall transplant surgery can provide a patient with a new abdominal wall that, after extensive rehabilitation, will provide mobility and a more natural aesthetic appearance.
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
- •Abdominal wall defects as described above
- •Strong motivation to proceed with transplantation
- •Accepts dedicating at least 2 years towards extensive post transplant rehabilitation
- •Age between 18 and 60 years
- •Elapsed injury-to-transplant time of more than 6 months and less than 15 years
- •Reports sub-optimal outcome with conventional reconstructive procedures
- •Normal liver and kidney function tests:
排除标准
- •Record of poor compliance
- •Unable to receive adequate follow-up care
- •Unable to receive immune suppression either due to geographic or financial limitations
- •Unable to follow strict rehabilitation schedule.
- •Documented psychological disorder(s) or incomplete psychological clearance
- •Impaired renal or hepatic function
- •Active cancer with or without metastases
- •Severe cardiac/pulmonary dysfunction or other severe irreversible/uncorrectable disease
研究组 & 干预措施
Transplant recipients
The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.
干预措施: abdominal wall transplantation (Procedure)
Transplant recipients
The intervention is transplantatoin of abdominal wall tissues from an organ donor who is deceased to a recipient with a large abdominal wall defect.
干预措施: Immunosuppressive Agents (Drug)
结局指标
主要结局
allograft survival
时间窗: 5 years
次要结局
- infections(5 years)
- immune rejection episodes(5 years)
- donation of abdominal wall(5 years)
研究者
Bohdan Pomahac
Director, Plastic Surgery Transplantation
Brigham and Women's Hospital