Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Lesion area
研究概览
简要总结
To evaluate the effect of human amniotic membrane as a weekly dressing on chronic wounds in Epidermolysis Bullosa (EB) patients.
详细描述
Dried human amniotic membrane dressing were obtained from National center for radiation research and technology, Egypt (NCRRT), under commercial name REGE pro.
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
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- Patients diagnosed as EB wounds must be chronic
排除标准
- •Patients Must stop other line of treatment
- •Exclude patients have:
- •Autoimmune diseases
结局指标
主要结局
Lesion area
时间窗: 6 weeks
The lesion area from the first treatment is greater than 2 cm\^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm\^2).
Clinical progression sings
时间窗: 6 weeks
* After the first application time: White transperent color of granulation tissue appeared. * After the second application time: color dense of granulation tissue increased and covered all over the wound. * After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer. * After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color. * After the fifth and sexth application time: Skin layers development appeared.
次要结局
- Patient complain (upon the weekly questionnaire)(6 weeks)
研究者
Nashwa Radwan
Head of amniotic tissue laboratory, Principal Investigator
Egyptian Atomic Energy Authority