A Randomized Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix) in the Prevention of Hypertrophic Scar in Subjects Undergoing Caesarean Section
试验速览
- 阶段
- 4 期
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- summation of scar scores of modified Vancouver Scar Scale
研究概览
简要总结
Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.
详细描述
Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.
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
- 20 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
- •Those who understand and agree on the trial conditions
排除标准
- •Keloid (by present and past medical history)
- •Secondary infection, and/or dermatitis in and around c/s wound
- •Hypersensitivity to the study agent
- •(Pre)eclampsia
结局指标
主要结局
summation of scar scores of modified Vancouver Scar Scale
时间窗: week 12
次要结局
- summation of scar scores of mVSS 4 and 8 weeks after application(weeks 4, 8, 12)
- scar thickness 12 weeks after application(weeks 4, 8, 12)
- subjective satisfaction 12 weeks after application (VAS)(weeks 4, 8, 12)
- tolerability 4, 8, 12 weeks after application (index3)(weeks 4, 8, 12)
