NCT02668055已完成1 期
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.
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 78 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 5.3 months participated in other similar experiment
- •6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients
研究组 & 干预措施
TB4
Experimental
Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells in wound, stick with wound edge skin suture, with vaseline gauze bandaging, controlled side not adding slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes
干预措施: TB4 (Biological)
结局指标
主要结局
Frequency of Adverse Events
时间窗: 6 months
Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing
次要结局
- Relative Wound Area Regression of 40% of More at 6 Week(6week)
研究者
Xiaobing Fu
Academician
Chinese PLA General Hospital
研究点 (1)
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