Influence of a Silicone Gel (Dermatix®) on Thoracic Scar Formation After Harvesting of Autologous Rib Cartilage for Standardised Total Ear Reconstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
研究概览
简要总结
So far the evaluation of scar treatment was based on subjective criteria. The patient groups were divided into treated versus non-treated.
In this study we use patients undergoing ear reconstruction with autologous rib cartilage. The thoracic scar of harvesting the rib cartilage is routinely reopened after 3 month during second stage of reconstruction. Therefore we have a ideal model of clinical, physiological and histological scar evaluation in a homologous patient group.
All patients randomly treat one half of the scar with a silicone gel (Dermatix). The other half is untreated as an internal control.
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
- None
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with high grade microtia requiring a reconstruction with autologous rib cartilage
排除标准
- •diabetes mellitus
- •vascular disease
- •known allergic reaction to silicone
研究组 & 干预措施
1
Each patient uses the silicone gel on one half of the scar, leaving the other one blank as an internal control.
干预措施: Silicone gel (Dermatix®) (Drug)
结局指标
主要结局
Beausang's scar scale, skin elasticity (Cutometer®), skin moisture (Corneometer®), skin color (Chromameter®, Mexameter®), histological evaluation (HE, elastica, actin etc.)
时间窗: 45 minutes
次要结局
- allergic reaction compliance(retrospective)