Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- High resoluton ultrasonography
研究概览
简要总结
The goal of this clinical trial study: is to determine the effect Botulinum toxin type A iontophoresis in hypertrophic scars for post burned patients. The main question is it aims to answer is:
- Does Botulinum toxin type A iontophoresis may help in minimizing postburn hypertrophic scars?
- Participants will receive the treatment for 3 months.
- Assessment will be done before and after treatment.
详细描述
- Subjects:
Seventy-six Patients from both genders who have post burn hypertrophic scar will participate in this study. Their ages will be ranged 20 to 40 years. 2. Design of the study:
In this study the patients will be randomly assigned into two equal groups (38 patients for each group):
- Group A (Study group):
This group includes 38 patients who will receive botulinum toxin type A iontophoresis once monthly for 3 months, in additional to traditional physical therapy (Positioning, Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months. 2. Group B (Control group):
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with hypertrophic scar (3-6) months after burn healing.
- •Age range between 20-40 years.
- •Male and female patients will participate in the study.
- •All patients have a postburn hypertrophic scar at different body sites.
- •All patients enrolled on the study will have their informed consent.
排除标准
- •Patients with prior medical histories of cardiac arrhythmias.
- •Patients with cardiac pacemakers.
- •Patients with orthopedic implants.
- •Areas of skin with lesions and impaired sensation.
- •During pregnancy and breastfeeding.
- •Patient with diabetes mellitus.
- •Patients with a history of hypersensitivity or adverse reactions associated with (BTX_A).
- •Recent BTA administration 6 months before the study.
- •Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis.
研究组 & 干预措施
Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
The study group includes 38 postburn hypertrophic scar patients l receiving Botox iontophoresis once monthly for 3 months; in addition to their physical therapy program (Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months.
Botulinum toxin type A (Botox Allergan ®, Irvine, CA, USA) is used. 100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 4 U/0.1 mL) is being administered once a month for a total period of three months.
The dose will be adjusted to 2.5 U/cm2 of the scar. The dose shouldn't exceed 100 units per session.
干预措施: Iontophoresis drug delivery device (Device)
Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
The study group includes 38 postburn hypertrophic scar patients l receiving Botox iontophoresis once monthly for 3 months; in addition to their physical therapy program (Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months.
Botulinum toxin type A (Botox Allergan ®, Irvine, CA, USA) is used. 100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 4 U/0.1 mL) is being administered once a month for a total period of three months.
The dose will be adjusted to 2.5 U/cm2 of the scar. The dose shouldn't exceed 100 units per session.
干预措施: Traditional physical therapy (Behavioral)
Traditional physical therapy for postburn hypertrophic scar
This group includes 38 patients with postburn hypertrophic scar who will receive the traditional PT (deep friction massage, stretching and pressure therapy).
干预措施: Traditional physical therapy (Behavioral)
结局指标
主要结局
High resoluton ultrasonography
时间窗: Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment(after 3 months from the beginning of treatment).
High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency.
Patient and observer scar assessment scale
时间窗: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 3 months after treatment.
The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse.
次要结局
未报告次要终点
研究者
Hayam Mahmoud Aboulmaati Alnawagy
Assistant lecturer
Cairo University