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Publication Summary

Clinical and Pre-clinical Publications
Study Area

Burn wounds

Design

Prospective, randomized, controlled study

Study Finds Vomaris™ Bioelectric Technology Significantly Decreased Biofilm in Burn Patients

Chan RK, Nuutila K, et al.; Adv Wound Care (New Rochelle). 2023 Apr 11. doi: 10.1089/ wound.2023.0007. Epub ahead of print.

  • Early, short-term treatment with WED significantly decreased biofilm severity in all burn wounds.
  • Incidence of opportunistic pathogens such as Ralstonia pickettii and Serratia marcescens was significantly lower in WED-treated wounds compared to SoC.
  • WED may result in a therapy that is superior to silver alone.
Study Area

Wound biofilm infection

Design

Pre-clinical porcine mechanistic study

Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing

Barki KG, Das A, Dixith S, et al.; Ann Surg, 2017.

  • Tested ability of wireless electroceutical device (WED) to manage bacterial biofilm infection in vivo in porcine chronic wound biofilm infection model inoculated with Pseudomonas aeruginosa and Acinetobacter baumannii.
  • WED disrupted existing biofilm infection and prevented biofilm from forming.
  • WED repressed genes responsible for quorum sensing, disrupting bacteria’s ability to communicate and form biofilm.
Study Area

Diabetic wounds

Design

Prospective case series

Human Acellular Dermal Matrix Paired with Silver-Zinc Coupled Electroceutical Dressing Results in Rapid Healing of Complicated Diabetic Wounds of Mixed Etiology: A Novel Case Series

Cole W; Wounds. 2016;28(7):241-247.

  • Electroceutical wound dressing used in combination with human acellular dermal matrix in three complex cases (conventional care was unable to close wounds in up to two years).
  • All three cases healed fully within six weeks with this alternative treatment.
Study Area

WED in conjunction with NPWT

Design

Randomized controlled clinical trial

A Wireless Electroceutical Dressing Lowers Cost of Negative Pressure Wound Therapy

Ghatak PD, Schlanger R, Ganesh K, et al.; Adv Wound Care. 2015;4(5):302-311.

  • Thirty (30) chronic wound patients undergoing negative pressure wound therapy (NPWT) were randomized into two arms (control = NPWT standard of care with thrice weekly dressing changes and test
    = wireless electrical device [WED] + NPWT with twice weekly dressing changes).
  • WED + NPWT effectively decreased required dressing change frequency thrice to twice weekly without negatively impacting wound healing.
  • Cost of care with use of WED + NPWT was significantly lower than NPWT alone (p<0.05).
Study Area

Acute and chronic wounds

Design

Retrospective dual center review of wound healing outcomes

Demonstration of a Microcurrent-Generating Wound Care Device for Wound Healing within a Rehabilitation Center Patient Population

Whitcomb E, Monroe N, Hope-Higman J, et al.; J Am Coll Clin Wound Spec. 2013;4:32-39.

  • Evaluated differences in wound healing outcomes when treated with microcurrent-generating wound care device (MCD, n=18) vs. standard of care (SOC, n=20).
  • Study population of rehabilitation and long-term care patients with acute and chronic wounds of varied etiology.
  • MCD group wounds healed significantly faster (19.78 days) than SOC group (36.25 days) (p=0.036)
  • 83.3% of MCD group wounds healed monotonically vs. 50% of SOC group (p=0.018).
Study Area

Skin graft harvest sites

Design

Prospective single center clinical study

The Use of Bioelectric Dressings in Skin Graft Harvest Sites: A Prospective Case Series

Blount AL, Foster S, Rapp DA, et al.; J Burn Care Res. 2012;33(3):354-357.

  • Compared acute wound healing after skin grafting (n=13).
  • Half of each graft donor site was covered with a standard dressing (control) and half with a bioelectric dressing (test); both were covered with a semi-occlusive dressing.
  • One week post-op: significantly greater epithelialization with bioelectric dressing (71.8%) vs. control (46.9%) (p=0.015).
  • Blinded evaluator rated bioelectric dressing side visually superior in 92.3% of wounds.
Scientific Publications
Study Area

Anti-fungal properties

Design

In vitro

Ketoconazole Resistant Candida albicans is Sensitive to a Wireless Electroceutical Wound Care Dressing

Khona D, Roy S, Ghatak S, et al.; Bioelectrochemistry. 2021 Aug 4; 142:107921.

  • Tested whether wireless electroceutical dressing (WED, Procellera™) is effective against ketoconazole-resistant yeast Candida albicans.
  • In vitro model used to test WED, ketoconazole, and the combination of WED + ketoconazole against ketoconazole-resistant C. albicans.
  • WED significantly affected several critical pathways necessary for C. albicans viability. In contrast, silver alone was ineffective.
  • Wireless electroceutical dressing (WED) inhibited Candida albicans biofilm formation.
Study Area

 Anti-biofilm properties

Design

In vitro

Silver-Zinc Redox-Coupled Electroceutical Wound Dressing Disrupts Bacterial Biofilm

Banerjee J, Ghatak PD, Roy S, et al.; PLoS One. 2015 Mar 24;10(3):e0119531.

  • Tested wireless electroceutical device’s (WED) ability to inhibit Pseudomonas aeruginosa biofilm.
  • WED impaired biofilm formation and significantly impaired extracellular polymeric substance formation compared to two different controls (placebo dressing and silver dressing) (p<0.05).
  • WED impaired biofilm structures and caused significant cell death compared to controls (p<0.05).
  • Silver alone was unable to disrupt Pseudomonas aeruginosa biofilm.
Study Area

Anti-biofilm properties

Design

In vitro

Antibiofilm Efficacy Evaluation of a Bioelectric Dressing in Mono- and Multi-Species Biofilms

Kim H, Izadjoo MJ; J Wound Care. 2015 Feb 24;Suppl2:S10-14.

  • Tested a bioelectric dressing’s effectiveness against 10 clinical wound pathogens in monospecies and multispecies biofilm settings.
  • Bioelectric dressing was effective against monospecies and multispecies biofilm forming bacteria; demonstrated 100- to 1000-fold reductions in bacterial numbers compared to three controls.
Study Area

Re-epithelialization

Design

In vitro

Improvement of Human Keratinocyte Migration by a Redox Active Bioelectric Dressing

Banerjee J, Ghatak PD, Roy S, et al.; PLoS ONE. 2014 Mar 3;9(3):e89239.

  • Human keratinocytes exposed to bioelectric dressing (BED) demonstrated significantly accelerated cell migration. This effect was not observed with three controls (placebo, silver alone, zinc alone).
  • Cells exposed to BED’s electric fields demonstrated increased signaling and production of H2O2 (required for cell migration).
Study Area

Anti-bacterial properties

Design

In vitro

Antibacterial Efficacy Testing of a Bioelectric Wound Dressing Against Clinical Wound Pathogens

Kim H, Makin I, Skiba J, et al.; Open Microbiol J. 2014 Feb 21;8:15-21.

  • Examined in vitro antibacterial efficacy of bioelectric dressing against 13 wound pathogens.
  • The bioelectric dressing demonstrated bactericidal activity against antibiotic-sensitive multidrug-resistant strains and multiple antibiotic-resistant strains of wound pathogens; bacteriostatic activity against Enterococcus species.

K-215 Rev. A – Last updated: January 2024

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