Stable closure of acute and chronic wounds and pressure ulcers and control of draining fistulas from osteomyelitis in persons with spinal cord injuries: non-interventional study of MPPT passive immunotherapy delivered via telemedicine in community care.

Background: Micropore particle technology (MPPT) is a topical wound treatment. It is a passive immunotherapy, acting via the skin and wound microbiome without the use of antimicrobial action. In a general patient population, it removed wound infections 60% and initiated tissue regeneration 50% quicker than antibiotics and antiseptics. As MPPT supports the immune system, the aim was to confirm that MPPT is also effective in immunocompromised individuals. People with spinal cord injury (SCI) are immunodeficient due to their injury and not an underlying disease and recruit 50% fewer immune cells to an injury. The study, therefore, determined the efficacy, safety, health economics, and sustainability of MPPT in acute and chronic wounds and pressure ulcers in this patient population. Methods: Pressure ulcers in SCI persons are an orphan indication, patient variability is high, and ICH E10 excludes comparators due to ethical concerns. The study design was, therefore, a single-arm, non-interventional, observational, post-market surveillance study of MPPT for treating wounds and pressure ulcers and removing soft tissue infection in connection with draining fistulas in SCI persons. The study was based on telemedicine in community care. Results: The study included 44 wounds. All acute and chronic grade 1-4 wounds and pressure ulcers reached stable closure. In wounds acting as fistulas draining from an underlying, primary focus of infection, e.g., osteomyelitis, MPPT removed the soft tissue infection in approx. 2.5 months and supported regeneration, considerably reducing fistula sizes. Compared to standard care, per-wound cost savings were 51 to 94% depending on wound grade and age, and substantial nursing resources were freed up. The telemedicine approach was well received by participants and supported independence and self-care. The use of antimicrobials, plastics, and synthetic polymers was essentially eliminated. MPPT did not require bed rest. Conclusion: The study confirmed that MPPT is safe and effective in treating acute and chronic wounds in immunocompetent and immunocompromised individuals, including wounds with antimicrobial-resistant infections. MPPT also removes soft tissue infections caused by an underlying primary focus of infection, such as osteomyelitis. Non-healing wounds currently represent an unmet clinical need. The findings suggest that a therapy acting via the microbiome without antimicrobial actions is effective.

Micropore Particle Technology Promotes Wound Healing, Whereas Polyhexamethylene Biguanide Causes Tissue Degeneration: A Case Report.

CASE REPORT: A 72-year-old woman with a nontraumatic spinal cord injury developed eschar on her lower right back. An underlying abscess was identified, which upon surgical debridement left a large wound extending down to the hip bone. In addition, the hip suffered from chronic osteomyelitis and was exposed at the bottom of the wound. The wound was initially treated for 5 weeks with Manuka honey but deteriorated further. Next, micropore particle technology (MPPT) was used. It cleared the wound of necrotic tissue based on autolytic debridement and removed the soft tissue infection; over a 3-month period, the wound reduced 50% in volume. Treatment approach was changed to polyhexamethylene biguanide (PHMB) and was applied as a gel once every second day to the wound. After 6 days, it was observed to cause tissue degeneration, disruption of the structure of the exposed bone, and the appearance of froth coming through the hip bone. A pain syndrome developed and the use of PHMB was terminated on day 10. After a wash-out period, the use of MPPT was reinitiated. Over the following 8 months, MPPT continued to control the infectious debris coming from the hip bone and promote healing without affecting the bone or causing side effects. CONCLUSIONS: It is generally assumed that the cytotoxic properties of antiseptics seen in cell culture experiments do not occur on wounds. The present case shows these cytotoxic properties are expressed on wounds, and they do disrupt tissues and tissue regeneration.

Time to Abandon Antimicrobial Approaches in Wound Healing: A Paradigm Shift.

Antimicrobial approaches (eg, antibiotics and antiseptics) have been used for decades in the treatment of infected wounds, ulcers, and burns. However, an increasing number of meta-analyses have raised questions regarding the therapeutic value of these approaches. Newer findings show that the body actively hosts an ecosystem of bacteria, fungi, viruses, and mites on its outer surfaces, known as the microbiome, as part of its defense against pathogens. Antimicrobials would disrupt this system and thereby work against the strategy the body has chosen. Recently, a new technology, micropore particle technology (MPPT), has been identified; it is not an antimicrobial but instead acts as a passive immunotherapy that disrupts the weaponry bacteria and fungi use to inhibit the immune system, allowing the immune system to recover. Clinical findings show MPPT removes wound infections 60% quicker than antibiotics and antiseptics and promotes the healing of chronic wounds that have not responded to antimicrobials. These effects are achieved without antimicrobial action and, considering the limited therapeutic benefits of antibiotics and antiseptics for wound infections, it is valid to question the use of antimicrobial approaches in wound care and the dogma that a reduction in microbial burden will lead to a reduction in infection. Instead, it may be time to consider a paradigm shift in wound healing away from antimicrobials and towards therapies that support the immune system and the microbiome. This review covers the increasing evidence that infections on external surfaces have to be treated fundamentally differently to internal infections.