The Combination Therapy of Nanofat Grafting and Platelet-Rich Plasma Injection Compared With Microfat Grafting and Platelet-Rich Plasma Injection Synergy in Treating Striae Distensae
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Immunohistochemical analysis
研究概览
简要总结
Striae distensae is caused by the fracture and damage of the elastic fibers and collagen fibers, which is still a difficulty to overcome. Based on the studies demonstrated that platelet-rich plasma(PRP) has positive effect on superficial scar, and nanofat and microfat are effective in treating atrophic scar. So in this clinical trial, the investigators are going to treat striae distensae by using two combination therapies. One is nanofat grafting and PRP injection synergy, and the other one is treated by microfat grafting with PRP injection.
详细描述
The participants were randomly assigned into two groups. Group A is treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times. Group B will be treated by microfat grafting onceevery three months for 2 times combined with PRP injection once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.Before and after the treatment, the striae distensae will be assessed subjectively by satisfaction assessment, and objectively by ultrasound and immunohistochemical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The striae distensae
- •Age ≤ 35 years old
排除标准
- •Skin allergy
- •Cicatricial diathesis
- •Skin inflammation or wound
- •Platelet dysfunction syndrome
- •Take anticoagulant drugs
- •Acute or chronic infection
- •Chronic liver disease
- •Active vitiligo, psoriasis, systemic lupus erythematosus
研究组 & 干预措施
Nanofat grafting and PRP injection
Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
干预措施: Nanofat grafting (Procedure)
Nanofat grafting and PRP injection
Striae diatensae will be treated by nanofat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
干预措施: Platelet-rich plasma (PRP) Injection (Procedure)
Microfat grafting and PRP injection
Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
干预措施: Microfat grafting (Procedure)
Microfat grafting and PRP injection
Striae diatensae will be treated by microfat grafting once every three months for 2 times combined with PRP injection once a month for 6 times.
干预措施: Platelet-rich plasma (PRP) Injection (Procedure)
结局指标
主要结局
Immunohistochemical analysis
时间窗: Change from baseline at 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the amount of elastic fiber and collagen fiber,etc. More collagen fiber generated better outcome of the treatments.
次要结局
- Ultrasound(Change from baseline width of striae at 3,6,9,12,15 months of the treatments.)
研究者
Li-Ling Xiao
Associate Chief of Department of Plastic Surgery
First Affiliated Hospital of Jinan University