Principal Investigators: Shay Soker, PhD; Co-PI Sean Murphy, PhD
Organization: Wake Forest University Health Sciences
Given the unpredictable future battle and casualty management environment, with definitive burn treatment occurring only post-evacuation, there is a need for effective and comprehensive trauma wound treatment capabilities deployable prehospital. Biological products such as amnion membrane shown efficacy in accelerating wound healing and preventing scarring, prevents dehydration and infection, and shown safety in a Phase I clinical trial. Our team includes diverse expertise to successfully lead the research including researchers with significant experience in natural biomaterials for skin wound therapy (Drs. Soker and Murphy), burn trauma surgeon (Dr. McMichael and a veterinarian pathologist (Dr. Koch) and a biostatistician (Dr. O’Connell).
The main objective of the study is to evaluate hAMP as a therapeutic treatment for preventing the conversion of partial-thickness skin burns to deep-partial or full-thickness burns and for promotion of wound healing. We hypothesize that hAMP will prevent burn wound deterioration and promote healthy skin regeneration in combat-relevant models of complex traumatic dermal injury.The proposed study entails 2 major aims. In Aim 1 we will test immediate and delayed hAMP application on burn conversion to mimic in theater treatment, in a porcine model of partial thickness burn wounds. Morphometric and histological analyses at early (2&7 days), middle (2&3 weeks) and late (4&8 weeks) timepoints will determine the effects on burn conversion and longer-term skin tissue regeneration. Contingent on satisfactory results, Aim 2 will focus on a Phase 1a study in patients with partial-thickness skin burn wounds, treated with hAMP within 24 hours post burn. Morphometric, pain and wound healing analyses for up to 6 months will determine the effects on wound closure and formation of normal skin.
The study will determine the effectiveness of hAMP treatment for preventing burn wound conversion compared to the standard of care (SoC) treatment only. It will further determine the effects of hAMP treatment for improved skin tissue regeneration and formation of normal skin. Finally, the study will determine the outcomes of immediate vs. delayed hAMP treatment for preventing conversion of burn wounds compared to the SoC treatment only.
At the completion of the study, we will establish the effectiveness of hAMP treatment as a potential burn treatment strategy to improve clinical outcomes and address gaps in standard of care efficacy. Evaluation of delayed hAMP application is also responsive to future combat needs, where early evacuation may not be possible, and prolonged, far forward burn treatment is necessary.