Evaluation of the Effect of CGF in Promoting Mechanical-stretch Induced in Vivo Skin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks
研究概览
简要总结
The purpose of this study is to evaluating whether autologous Concentrate Growth Factors(CGF) is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 14 to 65 years;
- •Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- •Persistent high level of expander internal pressure;
- •Need for further skin expansion;
排除标准
- •• Not fit for soft tissue expansion treatment;
- •Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
- •Significant renal, cardiovascular, hepatic and psychiatric diseases;
- •Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
- •BMI >30;
- •History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
- •History of allogenic bone marrow transplantation;
- •Long history of smoking;
- •Evidence of malignant diseases or unwillingness to participate.
研究组 & 干预措施
CGF injection group
Concentrate Growth Factors(CGF) will be harvested through centrifugation afte intravenous blood collection. Venous blood was collected in tube and then centrifuged in Medifuge system（Thermo Scientific）. About 2ml liquid CGF can be harvested from 9ml venous blood. Patients will receive autologous CGF injection subdermally to expanded skin at the density of 0.02 ml/cm2.
干预措施: CGF injection (Procedure)
Control group
0.9% saline will be injected into expanded skin for control study. Patients will receive saline injection subdermally to expanded skin at the density of 0.02 ml/cm2.
干预措施: Control (Procedure)
结局指标
主要结局
To Measure the Change in Inflation Volume of the Silicone Expander From Baseline at 8 Weeks
时间窗: baseline and 8 weeks post treatment
Record the inflation volume(ml) of each expander with the maintained inner pressure. The inflation volume was recorded according to the injection volume during expansion.
次要结局
- To Measure the Texture of Expanded Flap With Canfield's Visia Scanner(baseline and 8 weeks post treatment)
- Occurence of Major Adverse Events(Up to approximately 24 months after study start)
研究者
Qing-FengLi Li,MD
M.D., Ph.D.,Head of PRS Department
Shanghai Jiao Tong University School of Medicine