Antimicrobial dermal matrices to promote infection free wound closure in cutaneous wounds

概述：该CRP项目旨在使监管审批和加速

Overview: This CRP project aims at enabling regulatory clearance/approval and accelerating commercial availability of a self-assembly peptide-based matrix (G4Derm) for the management of wounds. Wound care is currently an expensive, multistep, and often cyclic process in which wounds are treated with sequential products to 1) remove pathogens with antibiotics, 2) promote a healthy cellular environment through hydrogel application, and 3) close the wound with skin substitutes. The proposed product, G4Derm, is capable of simultaneously removing drug- resistant microbes through biophysical disruption of bacterial membranes, while promoting host tissue regeneration without added antibiotics or biologics. G4Derm can be used in inpatient and outpatient wound care clinics to heal patients infected with drug-resistant bacteria, and to reduce the 100,000 amputations performed each year in the US due to chronic wounds. Key words: tissue regeneration, infections, wound healing, biomaterials, antimicrobial Areas of application: tissue regeneration and repair, wound healing, infections Subtopic name: Biomedical (BM) Technologies Intellectual Merit: This CRP proposal will allow for completion of the FDA 510(k)-enabling data demonstrating safety and efficacy of G4Derm as an antimicrobial cell-scaffolding matrix that is simultaneously toxic to antibiotic-resistant bacterial strains, while remaining conducive to tissue regeneration. The product uses a charge-based mechanism to lyse bacterial membranes upon contact and has a porous structure to promote cellular infiltration and cell attachment. Broader Impact: This CRP funding would enable the regulatory clearance and product launch of G4Derm, providing healthcare systems with a novel antimicrobial technology that can eliminate even drug-resistant bacterial strains from infected wounds while simultaneously promoting wound closure via tissue regeneration. According to the Centers for Disease Control and Prevention Report, antibiotic-resistant bacteria will cause serious infections in 2 million Americans each year, resulting in an estimated 23,000 deaths annually. Our ability to fight antibiotic-resistant bacteria is diminishing, and the pipeline of new potential antibiotic drugs is growing lean. Only 9 new antibiotics have received FDA approval since 1998, of which only 2 of these incorporated novel mechanisms of action. Hence, the proposed product offers the unprecedented combination of simultaneous pathogen elimination and host tissue regeneration. As the antibacterial mechanism is biophysical, bacteria are unlikely to develop resistance to this product.