Living Tissue Engineering Skin Substitutes Safety and Efficacy Studies for the Treatment of Difficult to Heal Wounds
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds
详细描述
This study for 6 months for a single center, open, randomized, controlled clinical trials before and after itself, test contains preliminary screening, treatment and follow-up after discharge of the patient.After treatment in patients with early debridement, in the case of no infection of living tissue engineering skin substitute transplantation, observe the wound healing after transplantation, chronic wound evaluation activity of tissue engineering skin substitutes in the efficacy and safety of wound healing after transplantation.
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
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet difficult had 1 month or more to heal the wound patients
- •Who signed the informed consent of men or women older than 17 (pregnancy)
- •Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent
- •The process of mental stability, can finish the test
排除标准
- •Known allergic to bovine collagen or gao min physique
- •the wound is greater than the10cm×10cm
- •People with mental illness, drug abusers and or other items
- •Pregnant women,Prepare a pregnancy or breast feeding women
- •3 months participated in other similar experiment
- •Serious infectious disease not controller
- •With surgery, such as severe trauma stress situation
- •Can not meet the requirement of the long-term follow-up of patients
结局指标
主要结局
Frequency of Adverse Events
时间窗: 6 months
Frequency and severity of Adverse Events
次要结局
- Relative Wound Area Regression of 40% or More at 6 Week(6 week)
研究者
Xiaobing Fu
Academican
Chinese PLA General Hospital