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A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection

OBJECTIVE: Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn wound excision to manage bacterial load, 60% of the mortality from burns is attributed to bacterial biofilm infection. A low electric field (∼1 V) generated by the novel F...

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Autores principales: Chan, Rodney K., Nuutila, Kristo, Mathew-Steiner, Shomita S., Diaz, Victoria, Anselmo, Kristin, Batchinsky, Maria, Carlsson, Anders, Ghosh, Nandini, Sen, Chandan K., Roy, Sashwati
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2024
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10654645/
https://www.ncbi.nlm.nih.gov/pubmed/36855334
http://dx.doi.org/10.1089/wound.2023.0007
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author Chan, Rodney K.
Nuutila, Kristo
Mathew-Steiner, Shomita S.
Diaz, Victoria
Anselmo, Kristin
Batchinsky, Maria
Carlsson, Anders
Ghosh, Nandini
Sen, Chandan K.
Roy, Sashwati
author_facet Chan, Rodney K.
Nuutila, Kristo
Mathew-Steiner, Shomita S.
Diaz, Victoria
Anselmo, Kristin
Batchinsky, Maria
Carlsson, Anders
Ghosh, Nandini
Sen, Chandan K.
Roy, Sashwati
author_sort Chan, Rodney K.
collection PubMed
description OBJECTIVE: Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn wound excision to manage bacterial load, 60% of the mortality from burns is attributed to bacterial biofilm infection. A low electric field (∼1 V) generated by the novel FDA-cleared wireless electroceutical dressing (WED) was previously shown to significantly prevent and disrupt burn biofilm infection in preclinical studies. Based on this observation, the purpose of this clinical trial was to evaluate the efficacy of the WED dressing powered by a silver–zinc electrocouple in the prevention and disruption of biofilm infection. APPROACH: : A prospective, randomized, controlled, single-center clinical trial was performed to evaluate the efficacy of the WED compared with standard-of-care (SoC) dressing to treat biofilms. Burn wounds were randomized to receive either SoC or WED. Biopsies were collected on days 0 and 7 for histology, scanning electron microscopy (SEM) examination of biofilm, and for quantitative bacteriological analyses. RESULTS: In total, 38 subjects were enrolled in the study. In 52% of the WED-treated wounds, little to no biofilm could be detected by SEM. WED significantly lowered or prevented increase of biofilm in all wounds compared with the pair-matched SoC-treated wounds. INNOVATION: WED is a simple, easy, and rapid method to protect the wound while also inhibiting infection. It is activated by a moist environment and the electrical field induces transient and micromolar amounts of superoxide anion radicals that will prevent bacterial growth. CONCLUSION: WED decreased biofilm infection better compared with SoC. The study was registered in clinicaltrials.gov as NCT04079998.
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spelling pubmed-106546452023-11-03 A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection Chan, Rodney K. Nuutila, Kristo Mathew-Steiner, Shomita S. Diaz, Victoria Anselmo, Kristin Batchinsky, Maria Carlsson, Anders Ghosh, Nandini Sen, Chandan K. Roy, Sashwati Adv Wound Care (New Rochelle) Technology Advances OBJECTIVE: Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn wound excision to manage bacterial load, 60% of the mortality from burns is attributed to bacterial biofilm infection. A low electric field (∼1 V) generated by the novel FDA-cleared wireless electroceutical dressing (WED) was previously shown to significantly prevent and disrupt burn biofilm infection in preclinical studies. Based on this observation, the purpose of this clinical trial was to evaluate the efficacy of the WED dressing powered by a silver–zinc electrocouple in the prevention and disruption of biofilm infection. APPROACH: : A prospective, randomized, controlled, single-center clinical trial was performed to evaluate the efficacy of the WED compared with standard-of-care (SoC) dressing to treat biofilms. Burn wounds were randomized to receive either SoC or WED. Biopsies were collected on days 0 and 7 for histology, scanning electron microscopy (SEM) examination of biofilm, and for quantitative bacteriological analyses. RESULTS: In total, 38 subjects were enrolled in the study. In 52% of the WED-treated wounds, little to no biofilm could be detected by SEM. WED significantly lowered or prevented increase of biofilm in all wounds compared with the pair-matched SoC-treated wounds. INNOVATION: WED is a simple, easy, and rapid method to protect the wound while also inhibiting infection. It is activated by a moist environment and the electrical field induces transient and micromolar amounts of superoxide anion radicals that will prevent bacterial growth. CONCLUSION: WED decreased biofilm infection better compared with SoC. The study was registered in clinicaltrials.gov as NCT04079998. Mary Ann Liebert, Inc., publishers 2024-01-01 2023-11-03 /pmc/articles/PMC10654645/ /pubmed/36855334 http://dx.doi.org/10.1089/wound.2023.0007 Text en © Rodney K. Chan et al., 2024; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Technology Advances
Chan, Rodney K.
Nuutila, Kristo
Mathew-Steiner, Shomita S.
Diaz, Victoria
Anselmo, Kristin
Batchinsky, Maria
Carlsson, Anders
Ghosh, Nandini
Sen, Chandan K.
Roy, Sashwati
A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title_full A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title_fullStr A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title_full_unstemmed A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title_short A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection
title_sort prospective, randomized, controlled study to evaluate the effectiveness of a fabric-based wireless electroceutical dressing compared to standard-of-care treatment against acute trauma and burn wound biofilm infection
topic Technology Advances
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10654645/
https://www.ncbi.nlm.nih.gov/pubmed/36855334
http://dx.doi.org/10.1089/wound.2023.0007
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