Quantitative Measurements of the Skin Dermal Regeneration After Stromal Vascular Fraction Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Dermal thickness
研究概览
简要总结
This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.
详细描述
This study is a prospective, exploratory investigation aimed at exploring the efficacy of stromal vascular fraction (SVF) transplantation in treating exhaustion of dermal regenerative capacity during skin expansion. The dermal thickness, texture, and perfusion before and after SVF transplantation would be recorded and analyzed by a series of quantitative devices including laser 3D scanner, Doppler ultrasound, VISIA skin analyzer, CK skin analyzer, and indocyanine green angiography.
The trial aims to include patients experiencing dermal exhaustion during the process of skin soft tissue expansion. We will extract SVF components from autologous adipose tissue and injected intradermally into the expanded skin. The changes of dermis of expanded skin were recorded before the treatment (baseline), and at 4 weeks and 8 weeks follow-up timepoints after SVF transplantation. More specifically, skin surface area was measured using laser 3D scan; skin thickness and texture were detected by Doppler ultrasound, VISIA skin analyzer and CK skin analyzer; skin blood perfusion was analyzed using indocyanine green angiography.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •had undergone tissue expansion treatment;
- •show signs of deterioration of skin texture during expansion, including stretch marks or thinning of the dermis (<2mm) with no improvement after suspending expansion for 2 weeks;
- •require further expansion to achieve the size for defect reconstruction.
排除标准
- •Patients with serious underlying diseases such as cardiovascular or cerebrovascular disease, peripheral vascular disease, or impaired liver or kidney function;
- •Patients with a long history of smoking and alcohol use who have not quit smoking or drinking;
- •Patients allergic to iodine or iodine-containing preparations;
- •Patients with psychiatric disorders, lack of insight, or those who cannot accurately express themselves or cooperate;
- •Patients with contraindications for SVF transplantation, such as ulceration or infection of the expanded skin;
- •Patients with severely loose skin or insufficient subcutaneous fat tissue;
- •Patients who request to withdraw informed consent and exit the clinical trial.
结局指标
主要结局
Dermal thickness
时间窗: Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation
Using Doppler ultrasound to measure the full-thickness of skin dermis of the expanded skin. The measurements were conducted at the center of the expanded skin and other four points (above, below, left, right) around the center. The average value is taken to represent the dermal thickness of the patient's expanded skin.
次要结局
- Skin surface area(Baseline: before SVF transplantation (Baseline); Follow-up: 4 and 8 weeks after SVF transplantation)