Effect of Pulse Width of a 595-nm Flashlamp-pumped Pulsed-dye Laser on the Treatment Response of Keloidal and Hypertrophic Sternotomy Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- scar volume, scar height, scar color, scar elasticity were measured at baseline (day of laser treatment 1), Week 4 (day of laser treatment 2), Week 8 (day of laser treatment 3), Week 24 (12 weeks after the last treatment).
研究概览
简要总结
To investigate the effect of pulse width on the treatment response of keloidal and hypertrophic sternotomy scars to a 595-nm pulsed dye laser
详细描述
The pulse width of the previous model of pulsed dye laser was fixed at 0.45 millisecond, whereas the pulse widths of the latest model of PDL are tunable ranging between 0.45-40 milliseconds. The long-pulsed PDL has been proven to be safe and more effective in treating certain vascular abnormalities including adult port-wine-stain and small leg vein.9-12 In the present study, we would like to investigate the effect of pulse widths on the treatment response of keloidal and hypertrophic sternotomy scars to the 595-nm PDL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult subjects aged above
- •Subjects must be in good health as determined by the investigator.
- •Presence of keloidal and hypertrophic sternotomy scars for at least 6 months
- •Subjects must have no prior treatment of the scar within 1 month before the first treatment session.
- •Subject or authorized representative must sign Informed Consent Form prior to study enrollment.
排除标准
- •Female subjects known to be pregnant.
- •Subjects with scleroderma, connective tissue disorders, hematologic disorders, hepatitis, infection, or uncontrolled diabetes mellitus.
- •Subjects with photosensitive dermatoses such as Systemic Lupus Erythematosus (SLE)
- •Subjects with a documented positive HIV test.
- •Subjects who are on any types of anticoagulants.
- •Subjects who are habitual smokers of cigars, pipe tobacco, or cigarettes.
- •Subjects with history of radiation treatment at treatment sites.
- •Subjects who use of any types of treatment of scars at the treatment site within one month before the first treatment visit.
- •Subjects who are on medication that may interfere with wound healing or hemostasis.
- •Subjects that have not signed the Informed Consent Form.
结局指标
主要结局
scar volume, scar height, scar color, scar elasticity were measured at baseline (day of laser treatment 1), Week 4 (day of laser treatment 2), Week 8 (day of laser treatment 3), Week 24 (12 weeks after the last treatment).
次要结局
未报告次要终点