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

March 14, 2016 updated by: Mechthild Sinnig, MD, Kinderkrankenhaus auf der Bult

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30173
        • Pediatric Surgery Kinder- und Jugendkrankenhaus AUF DER BULT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: First investigational device
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
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.
Other Names:
  • Wireless microcurrent Stimulation Wetling W 200
ACTIVE_COMPARATOR: Second investigational device
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
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.
Other Names:
  • Wireless microcurrent Stimulation Wetling W 200
PLACEBO_COMPARATOR: ES Wetling W200 with white light
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
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
Other Names:
  • non-invasive Electrical Stimulation Lamp
PLACEBO_COMPARATOR: ES Wetling W200 with red light
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
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.
Other Names:
  • non-invasive Electrical Stimulation Lamp

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurements
Time Frame: up to 21 days
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
Time Frame: up to 21 days
The painkiller consumption per kg / body weight and day is captured through study completion
up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kinderkrankenhaus auf der Bult

Investigators

  • Principal Investigator: Mechthild Sinnig, MD, Kinder- und Jugendkrankenhaus Auf der Bult

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

November 1, 2017

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (ESTIMATE)

March 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

March 18, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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