NCT03842644已完成不适用
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
XiaoXi Lin1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年2月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Scar width
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.
详细描述
Primary measurement: the mean scar width calculated by standard photos with rulers.
Secondary measure: the probability of scar hyperplasia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The incision is not shorter than 3cm
- •Skin type is III/IV
排除标准
- •Any medical history of facial surgery, not included injection therapy, external medication or fat graft
- •Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
- •Patients with a history of keloid or family history of keloid
- •Patients with serious skin disorders, eg. serious psoriasis or dermatitis
- •Patients with severe systemic or congenital disease which may affect the patient's safety in this study
结局指标
主要结局
Scar width
时间窗: through study completion, an average of 1 year
scar width is measure by standard photo with ruler
次要结局
- Vancouver Scar Scale(through study completion, an average of 1 year)
- Hypertrophic scar rate(through study completion, an average of 1 year)
- Patient and observer scar assessment scale score(through study completion, an average of 1 year)
- Relative side effect(through study completion, an average of 1 year)
研究者
XiaoXi Lin
Professor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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