Clinical Use of the Extracorporeal Shock Wave Therapy in the Treatment of Pathological Post Burn Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Scar appearance
研究概览
简要总结
A prospective, randomized, controlled study. The patients were divided into two groups with twenty patients per group. The control group received the standard treatment for postburn scars. The treatment group received the standard treatment and treatment of postburn scars with Extracorporeal Shock Wave Therapy 512 impulses of 0.15mJ/mm 2 in each session, twice per week for 4 weeks.
The investigators assessed the appearance of scar with the Vancouver Scar Scale (VSS), pruritus and pain with Visual Analog Scale (VAS) before the start of the treatment and at 2 weeks and 5 months after the treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypertrophic post burn scars of approximately 64 cm2 surface area.
排除标准
- •Patients younger than 18 year.
- •Pregnant women.
- •Having a known skin condition (e.g. psoriasis, skin cancer etc.).
- •Immunosuppression.
- •Hemophilia .
- •Matured scars.
- •Scars located above the lungs, the bowels, the gonads or electronic implants.
研究组 & 干预措施
Control group
This group received pain and pruritus medication as needed, received the usual physical therapy as per the protocol of our burn unit, as well as compression garments, silicone sheets and gels and moisturizing cream twice a day. Additionally, the patients were advice on reducing sun exposure and applying +50SPF sunblock on a daily basis.
Extracorporeal Shock Wave Therapy group
This group received the same treatment as the control group plus Extracorporeal Shock Wave Therapy (The DermaPACE® System, SANUWAVE Health Inc., USA) with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.
干预措施: Extracorporal Shock Wave Therapy (Device)
结局指标
主要结局
Scar appearance
时间窗: 6 months from inclusion
Scar appearance by Vancouver Scar Scale. Minimum value 0. Maximum value 13. Higher scores mean a worse outcome.
次要结局
- Scar pruritus(6 months from inclusion)
- Scar pain(6 months from inclusion)