Therapeutic Effect of the Wireless Micro Current Stimulation in Pediatric Deep Dermal Burns and Scald Injuries

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The treated wound areas are examined daily during the dressing change by the study doctors and standardized photographed. The condition of the wound is detected in the wound documentation module of KIS. The end point of the wireless micro current stimulation is an epithelialization of the wound surface under investigation of> 95%. The detection of reepithelisation is performed by the investigators and objectified through a photo-image program. At the total absence of wound healing on day 16th, the patient receives the standard surgical therapy (skin grafting). If there is an absence of wound healing with less than 50% epithelisation after 3 weeks of wireless micro current stimulation therapy the patient will also receives the standard surgical treatment (skin graft). If the wound-epithelialisation at day 24 is greater than 50% but not> 95%, the wireless micro current stimulation will still be continued, but no longer than 4 weeks - until day 30.

Official Title
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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

Conditions
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Burns

Intervention / Treatment
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* Device: First investigational device
* Device: Second investigational device
* Device: ES Wetling W200 Placebo with white light
* Device: ES Wetling W200 Placebo with red light


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: known wound healing problems child abuse as the cause of the combustion different wound dressing treatment prior to transfer to our hospital

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First investigational device<br>official name of product: Wireless microcurrent Stimulation Wetling W 200 n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light. | Device: First investigational device<br>* The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light.<br>* Other names: Wireless microcurrent Stimulation Wetling W 200;|
| Active Comparator: Second investigational device<br>official name of product: Wireless microcurrent Stimulation Wetling W 200 n=47 patients The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light. | Device: Second investigational device<br>* The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light.<br>* Other names: Wireless microcurrent Stimulation Wetling W 200;|
| Placebo Comparator: ES Wetling W200 with white light<br>Placebo device - 'ES Wetling W200 Placebo with white light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light. | Device: ES Wetling W200 Placebo with white light<br>* The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.<br>* Other names: non-invasive Electrical Stimulation Lamp;|
| Placebo Comparator: ES Wetling W200 with red light<br>Placebo device - 'ES Wetling W200 Placebo with red light' n=47 patients The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light. | Device: ES Wetling W200 Placebo with red light<br>* The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.<br>* Other names: non-invasive Electrical Stimulation Lamp;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelialization of the examined wound area of> 95% | 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). | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurements | The secondary endpoints include the subjective pain. This is detected every 8 hours (starting at 8:00 am) during hospitalization and indicated by a validated, visual analogue pain scale through study completion | up to 21 days | 
| Pain killer consumption | The painkiller consumption per kg / body weight and day is captured through study completion | up to 21 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric burns, deep dermal wounds, wound healing, ChildPain Measurement, Treatment Outcome Wound Healing/physiology, wireless electric stimulation, wireless current stimulation, wireless technology, children, conservative treatment, deep dermal scalds, humans, deep dermal burns, burns, wound healing process