Evaluation of the Effect of Autologous Fat and SVF Transplantation in Promoting Mechanical-stretch Induced in Vivo Skin Regeneration
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 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 grafted fat transplantation or SVF transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.
详细描述
Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. This study is to evaluate the effects of autologous fat graft/SVF transplantation on accelerating skin regeneration and promoting tissue expansion process.
Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into three groups, named as the experimental group and the control group. Patients from the FAT-GRAFT group will have a liposuction and subdermal fat graft transplantation. Patients from the SVF-TRANSPLANTATION group will have a liposuction and SVF will be separated and transplanted intradermally to expanded skin. Patients from the control group will have saline injection.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age of 18 to 60 years;
- •Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
- •Implanted silicone expander of 80 to 600 ml in size;
- •History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
- •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.
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 of each expander with the maintained inner pressure.
Occurence of Major Adverse Events
时间窗: Up to approximately 24 months after study start
Including expanded flap ischaemia, necrosis, fluidify, infection, and all other adverse events
次要结局
- To Measure the Texture of Expanded Flap with VISIA scanner(4 weeks and 8 weeks post treatment)
- To Measure Expanded Skin Thickness by Ultrasound Scanning(baseline, 4 weeks and 8 weeks post treatment)
- To Measure the Size of Expanded Flap with 3D laser scanner and calculate the surface of expanded skin(baseline and 8 weeks post treatment)
研究者
Qing-FengLi Li,MD
Prof.
Shanghai Jiao Tong University School of Medicine