Botulinum Toxin to Improve Results in Cleft Lip Repair
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Vancouver Scar scale
研究概览
简要总结
Botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif) is widely used for facial rejuvenation and many other medical indications. It induces chemodenervation through its action on the presynaptic neuron, preventing release of acetylcholine, which leads to functional denervation of striated muscle for 2 to 6 months after injection. The use of botulinum toxin injection to reduce the facial scar is logical because this could reduce the tensile distracting force of the upper lip caused by the orbicularis oris muscle pull. Tollefson has demonstrate that botulinum toxin injection has decrease lip tension after primary lip repair in 3 children at 3-6 months of age The main aim of this randomized trial is to compare whether post-operative peri-surgical-injection of botulinum toxin into bilateral orbicularis oris muscles can improve scar formation for both primary and secondary cleft lip surgery.
详细描述
This is a randomized controlled trial primarily designed to compare the scarring after primary and secondary cleft lip repair using post-operative botulinum toxin injection. There will be 4 main groups in this study:-
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Study group I: For primary lip surgery, immediately after primary lip repair will received botulinum toxin injection (1-2U/kg, at 25U/mL) into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site (Tollefson TT 2006).
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Study group II: For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room.
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Control group I : Similar amount (in C.C.) of normal saline will be injected after primary lip surgery at 3 months of age.
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Control group II: Similar amount (in C.C.) of normal saline will be injected after revision lip surgery (secondary cleft lip repair).
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ELIGIBILITY 4.1 Inclusion criteria for the primary lip repair group (i) Baby born with cleft lip who will receive primary lip repair at 3 months of age (iii) Written informed consent given by parent/guardian.
4.2 Inclusion criteria for the secondary lip repair group (i) Adult > 16 years old. (ii) Moderate to severe secondary cleft lip and/or nose deformity that warrants corrective surgery.
(iii) Written informed consent given by parent/guardian/patient.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the primary lip repair group
- •Baby born with cleft lip who will receive primary lip repair at 3 months of age
- •Written informed consent given by parent/guardian.
- •Inclusion criteria for the secondary lip repair group
- •Adult > 16 years old.
- •Moderate to severe secondary cleft lip and/or nose deformity that warrants corrective surgery.
- •Written informed consent given by parent/guardian/patient.
排除标准
- •Those patient not fit inclusion criteria
研究组 & 干预措施
study group I
For primary lip surgery, immediately after primary lip repair will received botulinum toxin injection (1-2U/kg, at 25U/mL) into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site
干预措施: Botulinum Toxin Type A (Drug)
Study Group II
For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room.
干预措施: Botulinum Type A (Drug)
Control Group I
Similar amount as group I (in C.C.) of normal saline will be injected after primary lip surgery at 3 months of age.
干预措施: Normal Saline (Drug)
Control II
Similar amount (in C.C.) as Study Group II of normal saline will be injected after revision lip surgery (secondary cleft lip repair).
干预措施: Normal Saline (Drug)
结局指标
主要结局
Vancouver Scar scale
时间窗: 6 month
Vancouver scar scale measures pigmentation, vascularity, pliability and scar height on the postoperative 6 month F/U.
次要结局
- Ultrasonography scar measurement(6 month)
- Photographic measurement(6 month)