Therapeutic Effect of the Wireless Micro Current Stimulation in Pediatric Deep Dermal Burns and Scald Injuries
NCT ID: NCT02712580
Last Updated: 2016-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
188 participants
INTERVENTIONAL
2016-04-30
2017-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
ES Wetling W200 Placebo with white light
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
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.
ES Wetling W200 Placebo with red light
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.
Interventions
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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.
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.
ES Wetling W200 Placebo with white light
The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* child abuse as the cause of the combustion
* different wound dressing treatment prior to transfer to our hospital
18 Years
ALL
No
Sponsors
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Kinderkrankenhaus auf der Bult
OTHER
Responsible Party
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Mechthild Sinnig, MD
Head of burn center, Principal Investigator
Principal Investigators
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Mechthild Sinnig, MD
Role: PRINCIPAL_INVESTIGATOR
Kinder- und Jugendkrankenhaus AUF DER BULT
Locations
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Pediatric Surgery Kinder- und Jugendkrankenhaus AUF DER BULT
Hanover, Lower Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Albertini R, Villaverde AB, Aimbire F, Salgado MA, Bjordal JM, Alves LP, Munin E, Costa MS. Anti-inflammatory effects of low-level laser therapy (LLLT) with two different red wavelengths (660 nm and 684 nm) in carrageenan-induced rat paw edema. J Photochem Photobiol B. 2007 Nov 12;89(1):50-5. doi: 10.1016/j.jphotobiol.2007.08.005. Epub 2007 Sep 6.
Cramp AF, Noble JG, Lowe AS, Walsh DM. Transcutaneous electrical nerve stimulation (TENS): the effect of electrode placement upon cutaneous blood flow and skin temperature. Acupunct Electrother Res. 2001;26(1-2):25-37. doi: 10.3727/036012901816356036.
Cho MR, Thatte HS, Lee RC, Golan DE. Integrin-dependent human macrophage migration induced by oscillatory electrical stimulation. Ann Biomed Eng. 2000 Mar;28(3):234-43. doi: 10.1114/1.263.
Goldman RJ, Brewley BI, Golden MA. Electrotherapy reoxygenates inframalleolar ischemic wounds on diabetic patients: a case series. Adv Skin Wound Care. 2002 May-Jun;15(3):112-20. doi: 10.1097/00129334-200205000-00006.
Fiorio FB, Silveira L Jr, Munin E, de Lima CJ, Fernandes KP, Mesquita-Ferrari RA, de Carvalho Pde T, Lopes-Martins RA, Aimbire F, de Carvalho RA. Effect of incoherent LED radiation on third-degree burning wounds in rats. J Cosmet Laser Ther. 2011 Dec;13(6):315-22. doi: 10.3109/14764172.2011.630082.
Herberger K, Kornek T, Debus ES, Diener H, Augustin M. Electrotherapy of chronic wounds: evidence of clinical effectiveness and benefit. Wound Manage 2011;2:86 - 93.
Kaada B, Olsen E, Eielsen O. In search of mediators of skin vasodilation induced by transcutaneous nerve stimulation: III. Increase in plasma VIP in normal subjects and in Raynaud's disease. Gen Pharmacol. 1984;15(2):107-13. doi: 10.1016/0306-3623(84)90091-0.
Kamolz, Herndon, Jeschke, Verbrennungen: Diagnose, Therapie, Rehabilitation des thermischen Traumas, Springer, Wien New York; 2009; 2, S5- 23
Kloth LC. Electrical stimulation for wound healing: a review of evidence from in vitro studies, animal experiments, and clinical trials. Int J Low Extrem Wounds. 2005 Mar;4(1):23-44. doi: 10.1177/1534734605275733.
Mogens, S.; Wirsing, P.; Siemers, F.; Andersen, F. Healing of chronic wound by Wireless Micro Current Stimulation. 2011
Sebastian A, Syed F, Perry D, Balamurugan V, Colthurst J, Chaudhry IH, Bayat A. Acceleration of cutaneous healing by electrical stimulation: degenerate electrical waveform down-regulates inflammation, up-regulates angiogenesis and advances remodeling in temporal punch biopsies in a human volunteer study. Wound Repair Regen. 2011 Nov;19(6):693-708. doi: 10.1111/j.1524-475X.2011.00736.x. Epub 2011 Oct 19.
Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
Whelan HT, Smits RL Jr, Buchman EV, Whelan NT, Turner SG, Margolis DA, Cevenini V, Stinson H, Ignatius R, Martin T, Cwiklinski J, Philippi AF, Graf WR, Hodgson B, Gould L, Kane M, Chen G, Caviness J. Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001 Dec;19(6):305-14. doi: 10.1089/104454701753342758.
Zhao M, Pu J, Forrester JV, McCaig CD. Membrane lipids, EGF receptors, and intracellular signals colocalize and are polarized in epithelial cells moving directionally in a physiological electric field. FASEB J. 2002 Jun;16(8):857-9. doi: 10.1096/fj.01-0811fje. Epub 2002 Apr 10.
Zhao M, Song B, Pu J, Wada T, Reid B, Tai G, Wang F, Guo A, Walczysko P, Gu Y, Sasaki T, Suzuki A, Forrester JV, Bourne HR, Devreotes PN, McCaig CD, Penninger JM. Electrical signals control wound healing through phosphatidylinositol-3-OH kinase-gamma and PTEN. Nature. 2006 Jul 27;442(7101):457-60. doi: 10.1038/nature04925.
Other Identifiers
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1234567
Identifier Type: -
Identifier Source: org_study_id
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