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

NCT02712580 | Unknown DMC

• 1 other identifier: 1234567
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burns

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain measurements

  up to 21 days

• Pain killer consumption

  up to 21 days

Study Arms (4)

First investigational device

ACTIVE COMPARATOR

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

Second investigational device

ACTIVE COMPARATOR

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

ES Wetling W200 with white light

PLACEBO COMPARATOR

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

ES Wetling W200 with red light

PLACEBO COMPARATOR

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

Interventions

First investigational device 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.

Also known as: Wireless microcurrent Stimulation Wetling W 200

First investigational device

Second investigational device 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.

Also known as: Wireless microcurrent Stimulation Wetling W 200

Second investigational device

ES Wetling W200 Placebo with white light DEVICE

The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.

Also known as: non-invasive Electrical Stimulation Lamp

ES Wetling W200 with white light

ES Wetling W200 Placebo with red light DEVICE

The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.

Also known as: non-invasive Electrical Stimulation Lamp

ES Wetling W200 with red light

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• known wound healing problems
• child abuse as the cause of the combustion
• different wound dressing treatment prior to transfer to our hospital

Sponsors & Collaborators

• Kinderkrankenhaus auf der Bult: lead

Study Sites (1)

Pediatric Surgery Kinder- und Jugendkrankenhaus AUF DER BULT

Hanover, Lower Saxony, 30173, Germany

Location

Related Publications (15)

• 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.

  PMID: 17920925 BACKGROUND

• 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.

  PMID: 11394491 BACKGROUND

• 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.

  PMID: 10784088 BACKGROUND

• 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.

  PMID: 12055444 BACKGROUND

• 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.

  PMID: 21981305 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 6714637 BACKGROUND

• Kamolz, Herndon, Jeschke, Verbrennungen: Diagnose, Therapie, Rehabilitation des thermischen Traumas, Springer, Wien New York; 2009; 2, S5- 23

  BACKGROUND

• 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.

  PMID: 15860450 BACKGROUND

• Mogens, S.; Wirsing, P.; Siemers, F.; Andersen, F. Healing of chronic wound by Wireless Micro Current Stimulation. 2011

  BACKGROUND

• 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.

  PMID: 22092840 BACKGROUND

• 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.

  PMID: 27429287 BACKGROUND

• 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.

  PMID: 11776448 BACKGROUND

• 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.

  PMID: 11967227 BACKGROUND

• 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.

  PMID: 16871217 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Mechthild Sinnig, MD

  Kinder- und Jugendkrankenhaus AUF DER BULT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mechthild Sinnig, MD

CONTACT

004951181154423; sinnig@hka.de

Katharina Schriek, MD

CONTACT

004951181154507; schriek@hka.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of burn center, Principal Investigator

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: March 18, 2016
• Study Start: April 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)