Overview: This Fast track project aims to test the feasibility of a self-assembly peptide hydrogel for the treatment of wounds. Wound care is currently an expensive, multistep 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. Thus, the proposed product G4Derm is capable of simultaneously removing drug resistant pathogens through biophysical disruption of bacterial membranes, while promoting host tissue regeneration without added antibiotics or biologics. This product 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 Fast track proposal will generate 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 current 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: The broader impact of this Fast track proposal would be the development of a novel antimicrobial mechanism that can eliminate even drug-resistant bacterial strains from infected wounds. 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 bacterial elimination while promoting tisue regeneration. As the antibacterial mechanism is biophysical, bacteria are unlikely to develop resistance to this product.
Public Health Relevance Statement: Project Narrative The proposed product G4Derm is a flowable, antimicrobial skin scaffolding matrix that promotes infection free healing of wounds. This product is designed to incorporate three major benefits in a single material i) broad spectrum antimicrobial activity, ii) tissue scaffolding matrix, and iii) flowable properties to fill wounds of any size, shape and depth. This product is easy to apply and has the potential to mitigate 1.7 million infections and 99,000 deaths associated with poor wound closure and antibiotic annually.
NIH Spending Category: Antimicrobial Resistance; Bioengineering; Biotechnology; Emerging Infectious Diseases; Infectious Diseases; Prevention; Regenerative Medicine
Project Terms: American; Amputation; Anti-Bacterial Agents; Antibiotic Resistance; Antibiotics; antimicrobial; Area; Bacteria; Bacterial Antibiotic Resistance; bacterial resistance; base; Biocompatible Materials; Biological; biomaterial compatibility; Biomedical Technology; Biophysics; Caring; Cell-Matrix Junction; Cells; Cellular Infiltration; Centers for Disease Control and Prevention (U.S.); Cessation of life; Charge; chronic wound; Clinic; Clinical; cost; Cutaneous; Data; Dermal; design; Development; Drug resistance; drug resistant bacteria; drug resistant pathogen; Effectiveness; efficacy study; Environment; Exhibits; Family suidae; fighting; Formulation; Gel; Goals; Gram-Negative Bacteria; Guidelines; healing; Health; Hospitals; Hydrogels; improved; In Vitro; in vivo; Infection; Infection prevention; innovation; Inpatients; Local Anti-Infective Agents; Mammalian Cell; Membrane; methicillin resistant Staphylococcus aureus; Methods; Modality; Multi-Drug Resistance; multi-drug resistant pathogen; Names; Natural regeneration; novel; Outcome; Outpatients; pathogen; Pathogenicity; Patients; Peptides; Phase; pre-clinical; preclinical safety; prevent; Process; Property; Quality Control; Repeat Surgery; Reporting; research clinical testing; Resistance development; resistant strain; Safety; safety study; scaffold; self assembly; Shapes; Site; Skin; Skin Substitutes; Small Business Innovation Research Grant; small molecule; Speed; Staphylococcal Infections; Staphylococcus aureus; Sterile coverings; Sterility; Structure; technological innovation; Testing; Thinness; TimeLine; tissue regeneration; tissue repair; tissue support frame; Tissues; Toxic effect; wound; wound closure; Wound Healing; Wound Infection
