NCT04532593尚未招募不适用
A Randomized, Placebo Controlled, Single-blinded Clinical Trial to Evaluate the Efficiency of Autologous Adipose Stem Cell in Promoting Skin Graft
Shanghai Jiao Tong University School of Medicine0 个研究点目标入组 75 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- Skin elasticity
研究概览
简要总结
Skin graft is a commonly used method in wound repair. The long-term outcome of skin graft is unsatisfied because of the complications of contraction, pigmentation and stiffness. In our preclinical researches, we found that adipose stem cell can improve the texture of grafted skin and reduce contraction. In this trial, we will evaluate the efficiency and safety of autologous adipose stem cells in improving skin graft outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 6-70 years old;
- •Gender: male and female;
- •Scar, surface tumor or soft tissue defect evaluated to be suitable for skin grafting;
- •With two skin grafting areas and the edges more than 4cm apart;
- •Sign informed consent, participate in the study and be able to cooperate with the follow-up.
排除标准
- •Those who are not suitable for skin grafting;
- •There who are with local lesions in the operation area, such as infection, blood supply disturbance, delayed healing history, decreased soft tissue vitality, history of radiotherapy or going to receive radiotherapy, active ulcer, etc;
- •With severe medical diseases (such as diabetes, hepatitis, coronary heart disease, arteriosclerosis, glomerulonephritis, autoimmune diseases, etc.) were complicated;
- •Those who are receiving anticoagulant therapy and cannot suspend treatment;
- •Those who are with abnormal blood routine test, abnormal coagulation function, abnormal cardiac function, abnormal liver function or renal function evaluated by researchers according to the laboratory examination and other clinical signs and symptoms,
- •Those who can't tolerate the operation risk according to the surgeon's evaluation;
- •Pregnant and lactating women;
- •Those who have mental illness, have no insight, can not express and cooperate with each other;
- •Participant in other clinical trials within 30 days before the screen visit of this trial;
- •Those who have not signed the informed consent.
结局指标
主要结局
Skin elasticity
时间窗: 6 months
Skin elasticity analyzed by Cutometer. The R2 value is used to evaluated the skin elasticity.
次要结局
- POSAS questionnaire of investigator(12 months)
- Skin elasticity(12 months)
- POSAS questionnaire of patient(12 months)
- Skin color(12 months)
研究者
Qing-FengLi Li,MD
Director, Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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