NCT01158196Unknown3 期
Effect of Infra-red Diode Laser on Improvement of Surgical Scar and on the Prevention of Excised Keloids Recurrence-Pilot Study
Ekkyo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
研究概览
简要总结
A pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. The aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. The keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Skin type from I to VI (Fitzpatrick classification scale)
- •Scar longer than 4cm for plastic surgery's patients OR scar longer than 2cm for keloid patients
排除标准
- •Malignant tumor pathology
- •Infectious or viral skin disease
- •Immunosuppressive pathology and/or immunosuppressive treatment,
- •Long-term corticosteroid treatment
- •Pregnant woman
结局指标
主要结局
treatment tolerability assessed by natures, intensity and incidences of the side effects, with a special oversight of skin burn lesion
时间窗: 10 days after surgery or excision
次要结局
- improvement of scarring for plastic surgery group(12 months after surgery)
- keloid recurrence, an intralesional corticotherapy will be set up as soon as there is a recurrence.(12 months after excision)
- quality of life assessment for keloid group(12 months after excision)
- Socio and medical economic evaluation for keloid group(12 months after excision)
研究者
研究点 (1)
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