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

Children's Hospital Auf der Bult

Status: Unknown

Conditions: Burns

Treatments: Device: Second investigational device; Device: ES Wetling W200 Placebo with red light; Device: ES Wetling W200 Placebo with white light; Device: First investigational device

Study type: Interventional

Funder types: Other

Identifiers

NCT02712580

1234567

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 188 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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188 participants in 4 patient groups, including a placebo group

First investigational device

Active Comparator group

Description:

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.

Treatment:

Device: First investigational device

Second investigational device

Active Comparator group

Description:

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.

Treatment:

Device: Second investigational device

ES Wetling W200 with white light

Placebo Comparator group

Description:

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.

Treatment:

Device: ES Wetling W200 Placebo with white light

ES Wetling W200 with red light

Placebo Comparator group

Description:

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.

Treatment:

Device: ES Wetling W200 Placebo with red light