跳至主要内容
临床试验/NCT02668055
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

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

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

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

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaobing Fu

Academician

Chinese PLA General Hospital

研究点 (1)

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