Efficacy and Safety of Intralesional Injection of Polidocanol 1% in Treatment of Keloids and Hypertrophic Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
we will inject intralesional polidocanol 1% in keloids and hypertrophic scars to decrease vascularity and decrease size of lesion compared to intralesional steroid as standard treatment line
详细描述
Patients and Methods
Ethical considerations:
This study will be submitted for approval by the Research Ethics Committee at Faculty of Medicine, Sohag University. Informed written consent will be taken from all participants.
Sample size:
Mean Vancouver Scar Scale (VSS) at the end of the follow up period will be considered the primary outcome of the study. We adopted 0.05alpha and 0.8 power values. With expected VSS mean values of 5, 4 and 3 for steroid, sclerotherapy and combined therapy, respectively, and pooled standard deviation value of 2, the anticipated sample size is expected to be 21 cases per group. We plan to recruit 30 cases per group to account for any dropouts.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients older than 16 years of both sex with keloids and/or hypertrophic scars ≤ year.
排除标准
- •Pregnancy, lactation.
- •Skin lesions, infection in the injection area.
- •Patients with systemic disease (diabetes mellitus, heart disease, cancer, mental illness).
- •Allergy to substances used.
- •Patients received treatment in previous 4 weeks.
- •Current anticoagulant therapy.
- •Active thromboembolic disease, use of oral contraceptives or other drugs affecting coagulation cascade.
- •History of venous or arterial thromboembolism.
- •Severe renal dysfunction.
研究者
Raghda Mohamed Hassan
assistent lecturer
Sohag University