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

概述：此CRP项目旨在实现监管审批和加速 用于管理的基于自组装肽的基质(G4Derm)的商业可用性 伤口的痕迹。伤口护理目前是一个昂贵的、多步骤的、往往是循环的过程，在这个过程中 伤口用顺序产品治疗，1)用抗生素去除病原体，2)促进 通过水凝胶应用创造健康的细胞环境，以及3)用皮肤封闭伤口 替代品。建议的产品G4Derm能够同时去除药物- 耐药微生物通过生物物理破坏细菌膜，同时促进宿主 无需添加抗生素或生物制剂即可实现组织再生。G4derm可用于住院患者 和门诊伤口护理诊所，以治愈感染抗药性细菌的患者，并 减少美国每年因慢性伤口而进行的10万次截肢手术。 关键词：组织再生、感染、伤口愈合、生物材料、抗菌剂 应用领域：组织再生和修复、伤口愈合、感染 副主题名称：生物医学(BM)技术 智力优势：这项CRP提案将允许完成FDA 510(K)-使能数据 展示了G4derm作为抗菌细胞支架基质的安全性和有效性 同时对抗药性细菌菌株有毒性，同时对组织有利 再生。该产品使用基于电荷的机制来裂解细菌膜 接触，并具有多孔结构，以促进细胞渗透和细胞附着。 更广泛的影响：这笔CRP资金将使监管机构获得批准并推出产品 G4Derm，为医疗保健系统提供了一种新的抗菌技术，可以消除 甚至是来自感染伤口的抗药性细菌菌株，同时促进伤口 通过组织再生闭合。根据疾病控制和预防中心的数据 报道称，耐药细菌每年会在200万美国人中造成严重感染， 每年造成约23,000人死亡。我们对抗抗药性细菌的能力 正在减少，潜在的新抗生素药物的流水线正变得越来越少。只有9个新的 自1998年以来，抗生素获得了FDA的批准，其中只有2种纳入了新药 行动机制。因此，拟议的产品提供了前所未有的组合 同时消除病原体和宿主组织再生。作为一种抗菌机制 是生物物理的，细菌不太可能对这种产品产生抗药性。

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.