The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in participant's panel reactive antibody (PRA) score at 6 months
研究概览
简要总结
The purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.
详细描述
Some burns will heal best with the use of temporary skin grafts from cadavers before covering the burns with grafts of the patient's own skin. This is the usual care for these types of burn injuries recommended by burn surgeons. This skin is applied in the operating room and removed after several days. During that time, the body's immune system will make antibodies to the skin. Normally, these antibodies are harmless. However, extra antibodies can make it difficult to find donors for transplants. The results of this study will be used to better understand how to treat a subset of burn patients with very severe burns in a way that allows them to receive tissue transplants (e.g. face transplants, hand transplants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Burns of deep partial thickness or full thickness depth totaling less than or equal to 10% total body surface area.
- •Injury requiring staged reconstruction with allograft skin (experimental group)
- •Injury requiring reconstruction with autograft skin (i.e. no cadaver skin; control group)
排除标准
- •Burns exceeding 10% total body surface area.
- •Pre-existing allosensitization at time of injury
- •Blood or blood product transfusion requirement
- •Pregnancy at the time of injury or during study period
- •History of solid organ transplant during study period
- •History of autoimmune disorder (systemic lupus erythematosus, etc.)
- •History of mechanical circulatory support (extracorporeal membrane oxygenation, ventricular assist device, total artificial heart) during study period
结局指标
主要结局
Change in participant's panel reactive antibody (PRA) score at 6 months
时间窗: Baseline to 6 months
Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
Change in participant's panel reactive antibody (PRA) score at 12 month
时间窗: Baseline to 12 months
Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
Change in participant's panel reactive antibody (PRA) score at 1 month
时间窗: Baseline to 1 month
Standard PRA assays will be performed on blood samples drawn from participants giving a percent score representing the number of reactions in the sample.
次要结局
未报告次要终点