Immediate Injection of Botulinum Toxin Type a After Keloid Scar Revision to Prevent Keloid Recurrence: a Prospective, Split-scar, Double-blind, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Keloid recurrence
研究概览
简要总结
The prospective, split-scar, double-blind, randomized controlled study will enroll the patients who are older than 20 years with progressive keloid lesion which is symmetric. Botulinum toxin A will be injected into half of each keloid revision wound immediately after skin closure. The scars will be assessed at 1-year follow-up with Vancouver Scar Scale (VSS), Patient and Observer Scar Assessment Scale (POSAS), and the Cutometer.
详细描述
Continuous variables will be reported as the mean ± standard deviation(SD). Each aspect of the VSS score, POSAS score, and the Cutometer parameters of each scar half between the BTA and control groups will be analyzed longitudinally using the paired t test. The interrater consistency will be evaluated using the Spearman rho. All analyses will be performed with IBM SPSS Version 23.0 (IBM Corp., Redmond, Wash.). A value of p < 0.05 is considered to indicate statistical significance.
The sample size was calculated based on the results of the investigators' aforementioned study published in 2019. Thirty patients underwent keloid revision and then received radiation therapy based on our treatment protocol. The postoperative Vancouver Scar Scale score was 4.15 ± 1.74. If treatment could improve VSS score by 1, which was considered clinically significant, approximately 26 patients would have been necessary to provide a result with a real significance (using the same SD and considering the standard α error of 0.05 and a power of 0.8). Assuming a 20% non-compliance rate for follow-up evaluation, the sample size was increased to 32 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (20 years or older)
- •Progressive keloid lesion that is bilaterally symmetric, mandibular area, anterior chest or suprapubic area, for example
- •At least 4 cm in length
- •Repeated or uncontrolled recurrence, and unendurable symptoms with poor response to conservative modalities
- •Valid written informed consent provided for surgery and trial inclusion
排除标准
- •Allergy to botulinum toxin
- •Previous botulinum toxin injection at the lesion within 6 months before enrollment
- •Myasthenia gravis
- •Focal infection signs
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Botulinum Toxin type A injection side
The Botulinum Toxin type A will be injected into the dermal layer before skin closure in keloid excision surgery. The concentration of Botulinum Toxin type A is 100 units in 2 mL and dosage is 8 units/cm. The maximal dose is 100 units for each participant.
干预措施: Botulinum Toxin Type A Injection [Botox] (Drug)
0.9% saline injection side
The 0.9% saline will be injected into the dermal layer before skin closure in keloid excision surgery. The dosage is 0.16 mL/cm.
干预措施: 0.9% Sodium Chloride Injection (Drug)
结局指标
主要结局
Keloid recurrence
时间窗: One year
The recurrence of keloid will be determined by clinical examination evaluated by a dermatologist.
次要结局
- Subjective symptoms(3, 6, 9 and 12 months)
- Objective symptoms(3, 6, 9 and 12 months)
- Vancouver Scar Scale(6 and 12 months)
- Scar firmness(6 and 12 months)