Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Scar width
研究概览
简要总结
Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years.The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.
详细描述
Background:
A scar represents dermal fibrous replacement tissue and results from a wound that has healed by resolution rather than regeneration. Undesirable scars, such as hypertrophic or keloid scars, occur most frequently over the anterior chest, shoulders, scapular area, lower abdomen and suprapubic region. Many of the investigators' microtia patients complained postsurgical hypertrophic scar. The incidence of hypertrophic scars after microtia reconstruction could be 6.29%.
Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years. The micropore tapes is very useful for facial scars. However, because of retroauricular contour and hairline, micropore tapes is difficult to retained over it place. Self-dry silicone gel is effective in both treatment and prevention of hypertrophic scar. It is consider first line for hypertrophic prevention in last update of facial scar care.
The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.
Patients and Methods:
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with microtia.
- •Written informed consent given by parent/guardian.
排除标准
- •Combined other craniofacial anomalies
- •Without permission of parent/guardian, without signed informed consent by parent/guardian.
研究组 & 干预措施
Experimental
Silicone gel applied for twice per day
干预措施: Silicone Gel (Drug)
结局指标
主要结局
Scar width
时间窗: 6 months after surgery
6 months after surgery, the scar width will be measured
次要结局
- Visual Analogue Scale(6 months after surgery)
- Vancouver Scar Scale(6 months after surgery)