Efficacy of Botulinum Toxin Injection in Reducing Scar Following Cheilorrhaphy: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Scar width
研究概览
简要总结
the aim of the study will be directed to evaluate clinically the effect of botulinum toxin type A injection on reducing the scar following cleft lip surgical repair.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with mild to severe unilateral cleft lip requiring repair
- •free from any systemic disease
- •with or without cleft palate
- •fit for general anesthesia
排除标准
- •patients with syndromic type of cleft lip
- •patients with systemic disease
研究组 & 干预措施
Group I : 16 patient with unilateral cleft lip treated with surgical procedure alone
干预措施: Modified Millard rotation advancement flap technique (Procedure)
Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery
干预措施: Modified Millard rotation advancement flap technique (Procedure)
Group II : 16 patients with unilateral cleft lip treated with botulinum toxin injection and surgery
干预措施: botulinum toxin injection (BTX A) before surgical intervention (Drug)
结局指标
主要结局
Scar width
时间窗: 3 and 6 months follow up
Scar width will be measured by independent examiners at two at two certain points using caliper: point 1 (Bottom) :above the white roll. point 2 (Top): below the nasal sill.
次要结局
- Vancouver scar scale(3 and 6 months)
研究者
Basel Saeed Sayed Ahmed Shamaa
Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University
Mansoura University