A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Vancouver Scar Scale Score
研究概览
简要总结
A new era of outcomes for pediatric burn patients has begun as burn care continues to improve. Unfortunately, complete restoration of burn-injured skin may be limited by the development of hypertrophic scarring. Treatment with laser therapy is one of the newest forms of scar therapy available. Although laser therapy has only been adopted by burn clinicians within the last several years, early evidence suggests that it may offer significant benefits. Thus the aim of this study is to investigate the effectiveness of using laser therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set of subjective and objective scar assessment tools.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 1-18 years at presentation
- •Patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist
- •Hypertrophic burn scar resulting from any etiology
- •Hypertrophic burn scar is ≥ 2 months post healing
- •Ability to complete English- language questionnaires
排除标准
- •Patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection)
- •Patients with a history of keloid scarring
- •Patients who cannot tolerate the intravenous (IV) sedation used to perform laser therapy procedures
- •Patients who have had previous laser therapy procedures
结局指标
主要结局
Vancouver Scar Scale Score
时间窗: Baseline (month 0) to month 12
The Vancouver Scar Scale is composed of four subscales which include pigmentation (range: 0 - 3), vascularity (range: 0 - 3), pliability (range: 0 - 5), and height (range: 0 - 3). Total Vancouver Scar Scale score refers to the score obtained by summing the values from each subscale (range: 0 - 14) with higher scores indicating a worse scar.
次要结局
- Patient and Observer Scar Assessment Scale Score(Baseline (month 0) to month 12)
- Scar stiffness measured by ultrasound elastographgy(Baseline(month 0) to month 12)
- Scar colour(Baseline(month 0) to month 12)
- Scar thickness(Baseline(month 0) to month 12)
- Scar stiffness measured by the DermaLab Combo® skin analysis device(Baseline(month 0) to month 12)
研究者
Joel Fish
Medical Director, Burn Program
The Hospital for Sick Children