Clinical Trial for Therapeutic Effect of Wireless Micro Current Stimulation Under Objectification of Combustion Depth by Laser Doppler Imaging in Children and Adolescents With Deep Dermal Burns and Scald Injuries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Epithelialization of the examined wound area of> 95%
研究概览
简要总结
This study will determine the effect of the wireless micro current stimulation in pediatric deep dermal burns and scald injuries. The clinical trial ist designed as a blinded, placebo-controlled, randomized, prospective, single-center study.
详细描述
Patients (m / w) aged 0-17 years with scalding and burning injuries will initially receive polyhexanide gel 0.02% in the ordinary course.
After 24-48 hours after the accident the wound depth is measured and documented with laser Doppler imaging (see inclusion criteria).
Then the patient is enclosed into the study.
From day 3 after the accident daily dressing changes are performed with possibly slight analgesic medication (ibuprofen 10 mg / kg ) and if necessary under sedation with midazolam 0.5 mg / kg po. Here, a 30-minute-treatment with the wireless micro current stimulation or the placebo lamp is performed.
For visual support of the process of the colorless wireless microcurrent therapy / colorless placebo therapy the medical device has an additional light source (red and white color). So, in addition, both (the control and the placebo) groups are divided in one group with colorless intervention (white light) and a group with red light. The main aspect is to avoid bias.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inpatients (m / w)
- •wound area greater than 0.5% and less than / or equal to 3% of the body surface
- •IIb ° combustion depth verified by Laser Doppler Imaging
- •Burn / scalds not older than 48 hours
- •Participation willingness of the patient
- •willingness to participate and written informed consent of both parents (or legal guardian) of the patient
排除标准
- •known wound healing problems
- •child abuse as the cause of the combustion
- •different wound dressing treatment prior to transfer to our hospital
结局指标
主要结局
Epithelialization of the examined wound area of> 95%
时间窗: up to 30 days
The primary endpoint of the trial is a epithelialization of the examined wound area of\> 95%. The primary endpoint is the time to reach a epithelialization of the wound defect\> 95%, measured in days since initial treatment (= initial treatment of the wound). In absence of wound healing after initial treatment and study treatment, the then usual surgical treatment for deep dermal wounds will be performed in patients (skin graft).
次要结局
- Pain measurements(up to 21 days)
- Pain killer consumption(up to 21 days)
研究者
Mechthild Sinnig, MD
Head of burn center, Principal Investigator
Kinderkrankenhaus auf der Bult