Draft:Bioelectric bandage

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

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.

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.

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.

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, 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.

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.
• Making antimicrobial resistant strains of Candida albicans antimicrobial sensitive.
• Cross-talk with keratinocytes via redox-dependent processes, improving keratinocyte migration, a critical event in wound re-epithelialization.

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.

Clinical in vivo:

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

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.