Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Physician global assessment for the treated and control region (PhGA)
研究概览
简要总结
Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.
Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.
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 (Investigator)
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 planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
- •Age at least 18 years old.
- •Patient able and willing to give written informed consent
排除标准
- •Patients with planned surgical intervention on hands, feet and genital area
- •Patients with a history of photodermatoses
- •Patients with a history of keloids
- •Patients with a history of adverse outcomes related to PDL
结局指标
主要结局
Physician global assessment for the treated and control region (PhGA)
时间窗: Before start of the study, 1 and 6 months after treatment
Patient global assessment for the treated and control region (PGA)
时间窗: Before start of the study, 1 and 6 months after treatment
次要结局
- Assessment of scar color by colorimetry(Before start of the study, 1 and 6 months after treatment.)
- Assessment of scar tickness by ultrasound measurements(Before start of the study, 1 and 6 months after treatment.)
- Assessment of viscoelasticity by Cutometer measurements(Before start of the study, 1 and 6 months after treatment.)
- Clinical scar assessment by the Vancouver Scar scale and POSAS scale.(Before the start of the PDL treatment, and 1 and 6 months after the last treatment.)