Evaluation of Botulinum Toxin Injection in Reducing Lip Scar Following Cleft Lip Repair (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in cleft scar
研究概览
简要总结
A cleft lip is a congenital defect resulting from failing to merge developmental processes in the Orofacial region. One of the most common complications surgeons fear after cleft lip repair is a hypertrophic scar. A cleft scar negatively affects a patient's appearance, psychology, and function. Several techniques have been proposed to improve lip scars such as steroid therapy, laser therapy, and silica gel. Despite such efforts, the results were still unsatisfactory. Botulinum Toxin injections may provide a more reliable method
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
- 0 Minutes 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With mild to severe cleft lip deformity requiring repair.
- •Neonates up to 1 year of age.
- •Patients with or without cleft palate.
- •Systemically healthy patients.
- •Patients follow postoperative instructions provided by their legal guardians.
排除标准
- •Patients with a syndromic type of cleft lip.
- •Patients suffering from relevant systemic and metabolic diseases.
- •Patients suffering from immunosuppressive diseases.
- •Patients suffering from neuromuscular disorders like Myasthenia Gravis.
- •Patients with special needs.
结局指标
主要结局
Change in cleft scar
时间窗: 2 weeks, 3 months, 6 months
Vancouver Scar Scale: This scale focuses on four parameters: scar height and thickness, pliability, vascularity, and pigmentation to generate a score ranging from 0 to 13 point
次要结局
- Change in scar width(2 weeks, 3 months, 6 months)
- Change in lip height(2 weeks, 3 months, 6 months)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University