Comparison of outcomes in patients undergoing scar revision with infiltration of adipose derived stromal vascular fraction versus scar revision alone: An Open Label Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
研究概览
简要总结
Study investigates whether intraoperative infiltration of adipose-derived stromal vascular fraction (SVF) during scar revision improves scar quality and reduces scar width compared to scar revision surgery alone in patients with scars over exposed areas such as the face, neck, forearm, and hand. The study recruits subjects aged 15–45 with scars longer than one year and measures outcomes using both clinical and ultrasound scar width evaluations, as well as the Patient and Observer Scar Assessment Scale (POSAS). There are two arms: one group receives SVF infiltration in addition to scar revision, while the other receives only conventional scar revision. Methodology includes the extraction and mechanical processing of adipose tissue for SVF preparation and standardized intraoperative administration. A minimum sample size of 52 (26 per group) is calculated and block randomization ensures balanced allocation. The primary outcomes are assessed six months post-procedure. The study intends to generate evidence for the effectiveness of SVF in improving surgical scar outcomes, potentially influencing clinical practice in scar management
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Excessive scars (wide, atrophic and hypertrophic scars) following surgery, trauma or burn on the face, neck, forearm and hand for more than 1 year
- •Scar length less than 10cm and width less than 5cm
- •Not a part of any other trial or research project
- •BMI more than 20.
排除标准
- •1.Pregnancy and lactation
- •Previous scar treatments for the same scar 3.Skin malignancies 4.Connective tissue disorders 5.Keloids 6.Not willing for consent.
研究者
Mary Treasa Pouline
All India Institute of Medical Sciences, Patna
