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

概述：该 CRP 项目旨在实现监管许可/批准并加速 用于管理的自组装肽基质 (G4Derm) 的商业可用性 的伤口。目前，伤口护理是一个昂贵、多步骤且通常循环的过程，其中 使用连续产品治疗伤口，以 1) 用抗生素去除病原体，2) 促进 通过水凝胶应用营造健康的细胞环境，3) 用皮肤闭合伤口 替代品。拟议的产品 G4Derm 能够同时去除药物 通过生物物理破坏细菌膜来抑制耐药微生物，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 可用于住院病人 和门诊伤口护理诊所来治愈感染耐药细菌的患者，并 美国每年因慢性伤口而实施的截肢手术减少 100,000 例。 关键词: 组织再生, 感染, 伤口愈合, 生物材料, 抗菌 应用领域：组织再生和修复、伤口愈合、感染 子主题名称：生物医学（BM）技术 智力价值：该 CRP 提案将允许完成 FDA 510(k) 支持数据 证明 G4Derm 作为抗菌细胞支架基质的安全性和有效性 同时对抗生素耐药菌株有毒，同时仍然有利于组织 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浸润和细胞附着。 更广泛的影响：这项 CRP 资金将使监管机构批准并推出产品 G4Derm，为医疗保健系统提供一种新型抗菌技术，可以消除 甚至来自感染伤口的耐药菌株，同时促进伤口愈合 通过组织再生闭合。据美国疾病控制与预防中心称 报告称，抗生素耐药细菌每年将导致 200 万美国人严重感染， 每年估计有 23,000 人死亡。我们对抗抗生素耐药细菌的能力 正在减少，而新的潜在抗生素药物的研发管线正在变得越来越精简。仅9新 自 1998 年以来，抗生素已获得 FDA 批准，其中只有 2 种含有新型抗生素 行动机制。因此，所提出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。作为抗菌机制 是生物物理的，细菌不太可能对该产品产生耐药性。

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.