Electromotive Drug Administration of Magnesium Sulphate on Hypertrophic Scar Post-Burn
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of hypertrophic scar thickness
研究概览
简要总结
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):
- Group A: Experimental: Magnesium Sulphate Iontophoresis for Postburn Hypertrophic Scar The study group includes 40 postburn hypertrophic scar patients will receive Magnesium Sulphate iontophoresis twice a week for 4 weeks; in addition to their traditional physical therapy program (deep friction massage, stretching and pressure therapy).
- Group B: Control: Traditional physical therapy for postburn hypertrophic scar This group includes 40 patients with postburn hypertrophic scar who will receive only the traditional PT (deep friction massage, stretching and pressure therapy) 2 sessions per week for 4 weeks
详细描述
-
Assessment measures and procedures:
-
High resolution ultrasonography [Time Frame: Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment (after 4 and 12 weeks 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 (Elrefaie et al., 2020). 2. Patient and observer scar assessment scale [Time Frame: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 4 and 12 weeks 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 (Lenzi et al., 2019). 2. Treatment procedures:
Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED) The phoresors II auto model PM850 IOMED allows the user to deliver a specific dose from 0 to 80 mA/min, control the current from 0 to 4 mA and automatically calculates required time for the selected dose. Current ramp-up and down, shut-off, error messages and safety checks are also performed automatically. The builtin option for manual current shut-off is an added safety feature (Teslim et al., 2013).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1-Patient with hypertrophic scar (3-6) months after burn healing. 2-Age range between 20-40 years. 3-Male and female patients will participate in the study. 4-All patients have a post-burn hypertrophic scar at different body sites. 5-All patients enrolled on the study will have their informed consent.
排除标准
- •1-Patients with prior medical histories of cardiac arrhythmias. 2-Patients with cardiac pacemakers. 3-Patients with orthopaedic implants. 4-Areas of skin with lesions and impaired sensation. 5-During pregnancy and breastfeeding. 6-Patient with diabetes mellitus. 7-Patients with a history of hypersensitivity or adverse reactions associated with (MgSO4).
- •8-Recent MgSO4 administration 6 months before the study. 9-Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis
结局指标
主要结局
Change of hypertrophic scar thickness
时间窗: 4 weeks
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 (Elrefaie et al., 2020).
The change of patient and observer scar assessment scale score
时间窗: 4 weeks
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 (Lenzi et al., 2019).
次要结局
未报告次要终点
研究者
Aya Gamal Fawzy El-Sayed
Dr
Cairo University