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Draft:Bioelectric bandage

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I. Definition

A bioelectric bandage, also known as a wireless electroceutical dressing (WED), is a medical-grade wound dressing embedded with moisture-activated microcell batteries made from elemental zinc and elemental silver.

Bioelectric bandage employs a patented matrix of moisture-activated microcell batteries comprised of elemental zinc and elemental silver embedded in a substrate.

The batteries are designed to mimic the skin’s physiologic electrical activity to reduce the risk of wound infection while supporting the skin’s natural healing process.

A bioelectric bandage, also known as a wireless electroceutical dressing (WED), is a medical-grade wound dressing embedded with moisture-activated microcell batteries made from elemental zinc and elemental silver.

II. Electricity and the skin

Throughout the human body, electrical fields regulate fundamental cell behavior.[1] [2] They govern cell proliferation, migration and differentiation and impact wound healing at the cellular and systemic level.

The skin is no different, and skin is considered the largest battery in the body.[3][4][5] Electrical fields exist naturally in the skin, creating surface energy potential (voltage) known as transepithelial potential (TEP).[1][5] The skin naturally creates and uses this electric energy to drive the healing process.

Electric fields exist naturally in the skin, creating surface energy potential known as transepithelial potential (TEP).

III. Electricity is essential to wound healing

When a wound occurs that disrupts the epithelial barrier, it short-circuits the electric potential (TEP). The TEP at the wound site collapses to zero, creating a gradient that drives the electric current flow from the surrounding healthy skin towards the more negative site – the wound. Electric field lines reorient themselves toward the wound edge, and microcurrents extend ~1 mm into the wound, healing from the outside edges.

Within the wound’s electric field, cells respond with a variety of biological and functional responses. These physiologic changes, known as the “current of injury”, drive wound repair and regeneration. When skin regeneration is completed, TEP is restored.[1][2][3][4][5][6]

When skin is wounded, an electrical change occurs. The electric field lines reorient themselves toward the wound; this physiologic change is called the “current of injury”.

IV. What is a bioelectric bandage?

Bioelectric bandages have microcell batteries embedded in the surface of the wound dressings that are activated by moisture with a conductive medium. A conductive medium is any solution that permits the flow of electrons. Some examples include saline solution and wound hydrogel.

Upon activation by moisture, bioelectric bandages wirelessly generate electricity in a process known as an oxidation-reduction or redox reaction. A redox reaction is a common, well-established reaction that involves the transfer of electrons between chemical species. The bioelectric bandage is designed to deliver an electrical microcurrent in approximately the same physiologic range as the skin. This impedance matching is essential because keratinocyte cells in the skin are pre-programmed to respond to activity within a certain electrical range. By generating microcurrents in a compatible range of 2-10 µA, the bioelectric dressing can “boost” the skin’s natural healing properties.

Bioelectric bandages have microcell batteries embedded in the surface of the wound dressings that are activated by moisture with a conductive medium.

V. Wound biofilm formation and disruption by electric field

A staggering 80% of chronic wound and surgical site infections are caused by bacteria sheltered within a biofilm.[7]

As the biofilm structure grows and matures, it becomes more resistant to destruction, leading to prolonged wound inflammation and disrupted quality of healing.

Bacteria commonly occur as free-floating planktonic microorganisms. When they invade a wound, they multiply rapidly to form aggregates. Using weak electrostatic interactions, called van der Waals forces, they attach and adhere to the wound surface in a process known as electrostatic adhesion.

Bacteria communicate through electrochemical signaling called quorum sensing, that enables bacteria to sense the density of neighboring bacteria and instruct their activity. They secrete chemical messengers that communicate with other bacteria and are translated into genetic signals that alter their behavior.

Simultaneously, electrical signaling is the result of ions released in waves from within bacteria. This ion wave coordinates bacterial metabolism, aiding in recruitment of neighboring bacteria and further transforming their behavior.

When messaging between bacteria grows strong enough, they begin to behave as a coordinated aggregate. They signal each other to secrete an extracellular polymeric substance, or EPS, that creates a biofilm shield around the bacteria, making them less accessible to the immune system and antibiotics. As the biofilm structure grows and matures, it becomes more resistant to destruction, leading to prolonged wound inflammation and disrupted quality of healing. Bacteria in a biofilm aggregate move in different ways to infect new areas and settle deeper into tissues following debridement.

Electrical signaling is the result of ions released in waves from within bacteria. This ion wave coordinates bacterial metabolism, aiding in recruitment of neighboring bacteria and further transforming their behavior.

The body’s immune system, alone or in combination with a drug, can usually kill planktonic bacteria. This ability to mitigate infection is crucial for resolution of wound inflammation and healing progression. However, once bacteria form biofilm, they are protected from attack by most immune cells and antibiotics, making biofilm infections notoriously difficult to treat.[8][9][10][11]

Not only are antibiotics challenged against biofilm, but the global rise in antibiotic resistance (AMR) poses a significant threat in the fight against bacterial infections. According to the World Health Organization (WHO), AMR is one of the top global public health and development threats. It is estimated that bacterial AMR was directly responsible for 1.27 million global deaths in 2019 and contributed to 4.95 million deaths. WHO has called for new solutions to this global health threat as drug development cannot outpace the increase in antibiotic resistance.[12]

VI. Scientific and clinical evidence

Bioelectric wound dressings have been shown to kill a broad spectrum of pathogens, including multi-drug resistant and biofilm-forming bacteria. In scientific, preclinical and clinical studies[13], bioelectric technology has demonstrated the ability to disrupt existing biofilm infection and prevent biofilm from forming. Bioelectricity has been demonstrated to disrupt quorum sensing, disrupting bacteria’s ability to communicate and form biofilm. This activity prevents biofilm formation, disrupts existing biofilm infection, and restores functional wound closure.[7][14]

There is a large body of published evidence demonstrating the healing and anti-microbial impact of bioelectric bandages.

In vitro evidence: Bioelectric bandages promoted:

  • Disruption of Pseudomonas aeruginosa biofilm.[14]
  • Making antimicrobial resistant strains of Candida albicans antimicrobial sensitive.[15]
  • Cross-talk with keratinocytes via redox-dependent processes, improving keratinocyte migration, a critical event in wound re-epithelialization.[2]

Pre-clinical in vivo: Bioelectric dressings:

  • Disrupted mixed species P.aeruginosa and Acinetobacter baumannii biofilm infection in a porcine wound model.
  • Prevented biofilm from forming.
  • Restored functional wound healing.[7]

Clinical in vivo:

  • Bioelectric dressings decreased biofilm infection in burn and traumatic wounds better than standard of care.[13]
  • Accelerated the rate of re-epithelialization.[16][17]

VII. Use of bioelectric bandages

Various electroceutical interventions have been tested in wound care. However, these systems often involve wired electrodes for direct application of electric current to stimulate the wound tissue. Tethering to electrical sources makes such design impractical for routine professional and consumer use.

Bioelectric bandages can be used for both acute and chronic wound care to reduce risk of infection and improve healing.

Modern bioelectric bandages generate electricity intrinsically, without reliance on external power sources. They are resistant to temperature changes and the elements, making them both durable and shelf-stable. Bioelectric bandages can be used for both acute and chronic wound care to reduce risk of infection and improve healing. Acute areas of application include surgery, trauma, and burns. Bioelectric bandages are also used for chronic wound care. There is significant interest in bioelectric bandages for military and veterinary applications.

Bioelectric bandages that are FDA cleared for prescription use are Procellera® Antibacterial Wound Dressings and JumpStart® Antimicrobial Wound Dressings. Bioelectric bandages are also available over-the-counter for superficial wounds, including cuts, scrapes, abrasions, irritations, and blisters. Currently, the only brand of bioelectric bandage available direct to consumers is PowerHeal™. Direct-to-consumer availability of bioelectric bandages represents an important advancement in advanced next-generation wound care.

Designed to mimic the skin’s physiologic electrical energy, bioelectric bandages are designed to reduce the risk of infection and speed healing.

References

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  1. ^ a b c McCaig, Colin D.; Rajnicek, Ann M.; Song, Bing; Zhao, Min (July 2005). "Controlling Cell Behavior Electrically: Current Views and Future Potential". Physiological Reviews. 85 (3): 943–978. doi:10.1152/physrev.00020.2004. ISSN 0031-9333. PMID 15987799.
  2. ^ a b c Banerjee, Jaideep; Ghatak, Piya Das; Roy, Sashwati; Khanna, Savita; Sequin, Emily K.; Bellman, Karen; Dickinson, Bryan C.; Suri, Prerna; Subramaniam, Vish V.; Chang, Christopher J.; Sen, Chandan K. (2014-03-03). "Improvement of Human Keratinocyte Migration by a Redox Active Bioelectric Dressing". PLOS ONE. 9 (3): e89239. Bibcode:2014PLoSO...989239B. doi:10.1371/journal.pone.0089239. ISSN 1932-6203. PMC 3940438. PMID 24595050.
  3. ^ a b Zhao, Min (August 2009). "Electrical fields in wound healing—An overriding signal that directs cell migration". Seminars in Cell & Developmental Biology. 20 (6): 674–682. doi:10.1016/j.semcdb.2008.12.009. ISSN 1084-9521. PMID 19146969.
  4. ^ a b Dubé, Jean; Rochette-Drouin, Olivier; Lévesque, Philippe; Gauvin, Robert; Roberge, Charles J.; Auger, François A.; Goulet, Daniel; Bourdages, Michel; Plante, Michel; Germain, Lucie; Moulin, Véronique J. (October 2010). "Restoration of the Transepithelial Potential Within Tissue-Engineered Human SkinIn Vitroand During the Wound Healing ProcessIn Vivo". Tissue Engineering Part A. 16 (10): 3055–3063. doi:10.1089/ten.tea.2010.0030. ISSN 1937-3341. PMID 20486795.
  5. ^ a b c FOULDS, I. S.; BARKER, A. T. (November 1983). "Human skin battery potentials and their possible role in wound healing". British Journal of Dermatology. 109 (5): 515–522. doi:10.1111/j.1365-2133.1983.tb07673.x. ISSN 0007-0963. PMID 6639877.
  6. ^ Moulin, Véronique J.; Dubé, Jean; Rochette-Drouin, Olivier; Lévesque, Philippe; Gauvin, Robert; Roberge, Charles J.; Auger, François A.; Goulet, Daniel; Bourdages, Michel; Plante, Michel; Germain, Lucie (April 2012). "Electric Potential Across Epidermis and Its Role During Wound Healing Can Be Studied by Using an In Vitro Reconstructed Human Skin". Advances in Wound Care. 1 (2): 81–87. doi:10.1089/wound.2011.0318. ISSN 2162-1918. PMC 3839018. PMID 24527285.
  7. ^ a b c Barki, Kasturi Ganesh; Das, Amitava; Dixith, Sriteja; Ghatak, Piya Das; Mathew-Steiner, Shomita; Schwab, Elizabeth; Khanna, Savita; Wozniak, Daniel J.; Roy, Sashwati; Sen, Chandan K. (April 2019). "Electric Field Based Dressing Disrupts Mixed-Species Bacterial Biofilm Infection and Restores Functional Wound Healing". Annals of Surgery. 269 (4): 756–766. doi:10.1097/sla.0000000000002504. ISSN 0003-4932. PMC 6568008. PMID 29099398.
  8. ^ Attinger, Christopher; Wolcott, Randy (June 2012). "Clinically Addressing Biofilm in Chronic Wounds". Advances in Wound Care. 1 (3): 127–132. doi:10.1089/wound.2011.0333. ISSN 2162-1918. PMC 3839004. PMID 24527292.
  9. ^ Prindle, Arthur; Liu, Jintao; Asally, Munehiro; Ly, San; Garcia-Ojalvo, Jordi; Süel, Gürol M. (2015-10-21). "Ion channels enable electrical communication in bacterial communities". Nature. 527 (7576): 59–63. Bibcode:2015Natur.527...59P. doi:10.1038/nature15709. ISSN 0028-0836. PMC 4890463. PMID 26503040.
  10. ^ Sender, Ron; Fuchs, Shai; Milo, Ron (2016-08-19). "Revised Estimates for the Number of Human and Bacteria Cells in the Body". PLOS Biology. 14 (8): e1002533. doi:10.1371/journal.pbio.1002533. ISSN 1545-7885. PMC 4991899. PMID 27541692.
  11. ^ Wolcott, Randall; Dowd, Scot (January 2011). "The Role of Biofilms: Are We Hitting the Right Target?". Plastic and Reconstructive Surgery. 127: 28S–35S. doi:10.1097/prs.0b013e3181fca244. ISSN 0032-1052. PMID 21200270.
  12. ^ "Antimicrobial resistance". www.who.int. Retrieved 2024-09-28.
  13. ^ a b Chan, Rodney K.; Nuutila, Kristo; Mathew-Steiner, Shomita S.; Diaz, Victoria; Anselmo, Kristin; Batchinsky, Maria; Carlsson, Anders; Ghosh, Nandini; Sen, Chandan K.; Roy, Sashwati (2024-01-01). "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". Advances in Wound Care. 13 (1): 1–13. doi:10.1089/wound.2023.0007. ISSN 2162-1918. PMID 36855334.
  14. ^ a b Banerjee, Jaideep; Ghatak, Piya Das; Roy, Sashwati; Khanna, Savita; Hemann, Craig; Deng, Binbin; Das, Amitava; Zweier, Jay L.; Wozniak, Daniel; Sen, Chandan K. (2015-03-24). "Silver-Zinc Redox-Coupled Electroceutical Wound Dressing Disrupts Bacterial Biofilm". PLOS ONE. 10 (3): e0119531. Bibcode:2015PLoSO..1019531B. doi:10.1371/journal.pone.0119531. ISSN 1932-6203. PMC 4372374. PMID 25803639.
  15. ^ Khona, Dolly K.; Roy, Sashwati; Ghatak, Subhadip; Huang, Kaixiang; Jagdale, Gargi; Baker, Lane A.; Sen, Chandan K. (December 2021). "Ketoconazole resistant Candida albicans is sensitive to a wireless electroceutical wound care dressing". Bioelectrochemistry. 142: 107921. doi:10.1016/j.bioelechem.2021.107921. ISSN 1567-5394. PMID 34419917.
  16. ^ Blount, Andrew L.; Foster, Sarah; Rapp, Derek A.; Wilcox, Richard (2012). "The Use of Bioelectric Dressings in Skin Graft Harvest Sites". Journal of Burn Care & Research. 33 (3): 354–357. doi:10.1097/bcr.0b013e31823356e4. ISSN 1559-047X. PMID 21979844.
  17. ^ Son, Ji Won; Koo, Do Yoon; Han, Seung-Kyu; Namgoong, Sik; Jeong, Seong-Ho; Dhong, Eun-Sang (2022-06-30). "Bioelectric Dressing on Skin Graft Donor Sites: A Pilot Clinical Trial". Journal of Wound Management and Research. 18 (2): 92–97. doi:10.22467/jwmr.2022.01942. ISSN 2586-0402.
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