Outcome Evaluation for Burn Scar Therapy-laser and Surgery in Patients in Formosa Fun Coast Explosion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Burn assessment by researchers
研究概览
简要总结
Protocol title： Outcome evaluation for burn scar therapy-laser and surgery in patients in Formosa Fun Coast Explosion
Objectives： The goal of this study is to evaluate the effectiveness of both lasers and operations on patients with major burn scar(>20% TBSA).
详细描述
Background： There is no gold standard treatment for burn scar treatment, especially for those with major burn scar. In the Formosa Fun-Coast Dust Explosion in 2015, lots of patients with major burn scar suffer from severe pathologic burn scar syndromes. The gold of the study is to evaluate the efficacy of both lasers and operations on major burn scars treatment in the past two years.
Study Design： To take the assessment of scar into account, the investigators use both objectives and subjective methods to evaluate the scar condition. In addition to the scale of scar, the investigators also use both sonography and HRV system to evaluate the expressions of scar. All evaluated tools used are the same as those used in 20160201R and 20160202R. The investigators also used previous records to check the patient's scar condition before these treatments.
Hypothesis： After treatment, scar conditions should get better than before. However, the investigators need more scientific statistics to evaluate the improve rate.
Key words： Burn scar, burn scar syndromes. Scar laser treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
evaluating in different medical groups
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>20% major burn scar, for 3 years
- •patients in Formosa FunCost Explosion
- •offering medical records, including laser and treatments
- •available for questionnaire evaluation and others' evaluation
- •those are willing to receive both sonography on scars and HRV evaluation
排除标准
- •those aren't willing to offer medical records
- •those aren't willing to fill questionnaire
- •those aren't willing to receive sonography on scars
研究组 & 干预措施
Laser and Surgery in patients with major burn scars
Evaluating patients with major burn scar after laser and surgical treatments Multiple-directions evaluation, including senior plastic resident, young resident, professional burn surgeons, senior nurse with burn scar, one non-medical patients(usually patients' family and friends)
干预措施: Laser and Surgery (Procedure)
结局指标
主要结局
Burn assessment by researchers
时间窗: Week 0
Burn scars are assessed using Vancouver scar scale by four plastic surgeons and a non-professional person.
Patients objective questionnaire
时间窗: Week 0
Patients objective questionnaires is used to evaluate subjects' sensation and life quality, in which pain, itchiness and sleep are evaluated by Visual Analogue Scale (VAS), Burn Itchiness Scale and Sleep Assessment Scale, respectively.
次要结局
- Autonomic nervous system analysis (selective)(Week 0)
- Scar evaluation by sonography (selective)(Week 0)
研究者
CHACHUN, CHEN
Plastic Surgeon
Shin Kong Wu Ho-Su Memorial Hospital