Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Patient satisfaction (Patient Assessment Scar Scale)
研究概览
简要总结
The Objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem cell injection in improvement of atrophic scar after scar revision.
详细描述
Forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. One group will be treated with scar revision only (control group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be injected with ADSCs after scar revision and the 4th group will be injected with a combination of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.
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
- None
入排标准
- 年龄范围
- 10 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with atrophic scar.
- •Age group: 5 years up to 35 years.
- •No previous medications, surgeries or laser therapy.
排除标准
- •Patient with hypertrophic or pigmented scar.
- •Patient with any blood disease.
- •Patients with lipodystrophy.
研究组 & 干预措施
stem cell, PRP
Adipose derived MSCs, versus Platelet rich plasma
干预措施: Stem cell (Biological)
stem cell, PRP
Adipose derived MSCs, versus Platelet rich plasma
干预措施: MSCs (Device)
Stem cell, Stem cell and PRP
Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
干预措施: Stem cell (Biological)
Stem cell, Stem cell and PRP
Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
干预措施: MSCs (Device)
结局指标
主要结局
Patient satisfaction (Patient Assessment Scar Scale)
时间窗: 6 months
Patient Assessment Scar Scale
次要结局
- Doctor satisfaction (Vancouver Scar Scale)(6 months)
研究者
Heba Mohamed Saad Eldien
Professor
Assiut University