Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Scar thickness
研究概览
简要总结
Keloids and hypertrophic scars are a common subject of dermatologic consultations. Therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.
详细描述
Silicone gel Sheeting (SGS) is one treatment modality that has proven effective for treatment of hypertrophic scar. One disadvantage of SGS is its application technique. To be effective, SGS must be applied on the scar for at least 12 hours daily. Topical silicone gel is a novel therapy that has shown promising result on scar prevention. However, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •subjects at least 18 years old
- •subjects with hypertrophic abdominal scar
- •Have not received treatment on the scar at least 1 month prior to the enrollment.
排除标准
- •subject who has previous history of silicone allergy
- •subject who smoke cigarette
- •subject who was treated with x-rays irradiation in the past
结局指标
主要结局
Scar thickness
时间窗: 1, 2 and 5 months after initiation of treatment
次要结局
- Clinical assessment on overall scar appearance(1, 2 and 5 months after initiation of treatment)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University