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临床试验/CTRI/2025/11/098213
CTRI/2025/11/098213尚未招募不适用

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

Department of Burns and Plastic Surgery1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年12月10日最近更新:

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

发起方
Department of Burns and Plastic Surgery
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mary Treasa Pouline

All India Institute of Medical Sciences, Patna

研究点 (1)

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