Comparative, Open, Randomized Trial Between Two Silicon-based Products to Treat Postoperative Scars
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluation of scars clinical improvement
研究概览
简要总结
This study aims to determine if a silicon-based gel and a silicon-based aerosol are effective in the treatment of postoperative scars.
详细描述
Improve the final aspect of scars, have been a challenge for medicine. Silicon based products have been used in various ways to prevent hypertrophic scars and keloids since 1980. A great percentage of studies shows that silicon-based products improves the aspect of scars in different pathologies. The main objective of this trial is to evaluate the efficacy, using the Vancouver scale, of two silicon-based products (Kelofin gel and Kelofin aerosol) after 180 days.
300 participants that meet all the inclusion criteria and are not classified in any of the exclusion criteria will be randomly allocated to one of thre treatment groups( Kelofin Gel, Kelofin Aerosol and no treatment) of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fitzpatrick skin phototype I, II, III or IV
- •Participant that has a recent surgical scar on remodeling phase (14 ± 7 days after surgery) from the following: breast plastic with inframammary incision (fold beneath the breast) or abdominoplasty, cesarean section, hysterectomy (removal of the uterus), oophorectomy (removal of ovaries), oophoroplasty (removal of nodules, cysts, etc. of the ovaries), salpingectomy (removal of the fallopian tubes), tubal ligation, exploratory laparotomy and ectopic pregnancy (pregnancy outside the uterus) (Pfannenstiel access road - transverse incision , below the navel and approximately one finger above the symphysis pubis).
排除标准
- •Skin Pathology in the product application area;
- •Diabetes;
- •Immune impairment;
- •Use of systemic corticosteroids or immunosuppressants;
- •Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis;
- •Background reaction to silicon-based products;
- •Other illnesses or medications that may interfere directly in the study or endanger the health of the participant.
结局指标
主要结局
Evaluation of scars clinical improvement
时间窗: 180 days
The scars will be evaluated by the Vancouver scale since the baseline visit until 180 days after the end of the treatment.
次要结局
- Evaluation of scars color improvement(180 days)
- Adverse events occurrence(180 days)
- Evaluation of scars measurement improvement(180 days)
- Participants satisfaction regarding the treatment(180 days)