NCT02712580

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Burns

Interventions

Type	Name	Description
DEVICE	First investigational device	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	Second investigational device	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	ES Wetling W200 Placebo with white light	The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
DEVICE	ES Wetling W200 Placebo with red light	The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-10-01
• Completion: 2017-11-01
• First posted: 2016-03-18
• Last updated: 2016-03-18

Locations

1 site across 1 country: Germany