Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Modified Vancouver Scar Scale
研究概览
简要总结
This study tries to prove that Cicatricell cream significantly reduces scarring with better wound appearance as compared to no treatment.
详细描述
At 1st post operative follow up visit, surgical incision(s) will be assessed for healing, after the sutures/staples/steri-strips are removed. To be included in the study the incision must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included. The incisions will be divided into two sections, using an imaginary line between top and bottom, or left and right. One side of the imaginary line will have cicatricell cream applied 2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary line will remain untreated. In the case of a bilateral incision, as in bilateral breast mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision and the 2nd incision will be untreated. The incision(s) will be its own control group. At the end of the treatment phase the incision(s) will be assessed again to compare the healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed IRB approved, written informed consent.
- •Patient from 18 to 60 years of age.
- •Patient who recently underwent a surgery involving linear surgical skin incisions of 5cm or more or patients with two exactly symmetrical separate incisions like bilateral inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included.
排除标准
- •Known skin allergies.
结局指标
主要结局
Modified Vancouver Scar Scale
时间窗: 8 weeks to 6 months
a scale of visual assessment of a scar
Improved wound appearance
时间窗: 8 weeks to 6 months
improved wound appearance by surface area measurement
Manchester Scar Scale
时间窗: 8 weeks to 6 months
A new quantitative scale for clinical scar assessment
improved wound appearance
时间窗: 8 weeks to 6 months
wound indentation measurement with caliper
次要结局
未报告次要终点