跳至主要内容
临床试验/NCT01004536
NCT01004536Unknown4 期

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

Samsung Medical Center4 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2010年10月最近更新:
适应症

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

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)

研究者

申办方类型
Other

研究点 (4)

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