Assessment of the Effect of Extracorporeal Shock Waves on Hypertrophy Scar
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change from baseline thick of scar
研究概览
简要总结
Assess the effect of extracorporeal shock waves on hypertrophy scar
详细描述
Prolonged and abnormal scarring after trauma, burns and surgical procedures often results in functional and cosmetic deformities. A wide variety of treatments have been advocated for pathologic scars regression. Unfortunately, the reported efficacy has been variable.Unfocused extracorporeal shock wave therapy is a feasible and non-intensive treatment. And it is an emerging option for the treatment of painful and retracting scars.
Administration of ESWT appears to result in significant improvements in scar clinical appearance, mobility and subjective pain. Clinical data were mirrored by histologic changes in connective tissue appearance and scar vascularization. Extracorporeal shock wave therapy is also an effective and conservative treatment for patients with aesthetic and functional sequela from burn scars. It is a feasible, cost-effective, well-tolerated treatment that can be used in the management of post-burn pathologic scars after the patients are briefed on the practical aspects of the treatment procedure.
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
- Single (Outcomes Assessor)
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
- •aged between 18 ~ 65 years old;
- •at least 4 weeks since onset of onset of wound;
- •healing wound with at least 6 scores in Modified Vancouver Scar Scale for more than four weeks
- •the most important of all, read and signed the inform concern of this study.
排除标准
- •patients with open wound;
- •oxygen dependent
- •having evidence of cognitive deficit;
- •having local infection, severe inflammation or otherwise lesion that is not suggestive for ESWT;
- •patient with serious medical problems, as uncontrolled hypertension, coagulopathy, recent severe hemorrhage, neoplasm, severe hepatic disease, epilepsy, cutaneous pathology, mental retardation.
研究组 & 干预措施
extracorporeal shock-wave
干预措施: extracorporeal shock-wave (Device)
massage
干预措施: massage (Other)
结局指标
主要结局
change from baseline thick of scar
时间窗: immediately post intervention, 1 month after, and 3 months
sonography for thick of scar
次要结局
- change from baseline Modified Vancouver Scar Scale(immediately post intervention, 1 month after, and 3 months)
- change from baseline Visual analogue scores (VAS)(immediately post intervention, 1 month after, and 3 months)
- change from baseline skin color(immediately post intervention, 1 month after, and 3 months)
- change from baseline Patient Scar Assessment Scale (POSAS)(immediately post intervention, 1 month after, and 3 months)
研究者
Li-Ru Chen,MD
MD
Mackay Memorial Hospital