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

概述：这个快速通道项目旨在测试一种自组装多肽水凝胶用于 伤口的治疗。目前，伤口护理是一个昂贵的、多步骤的过程，在这个过程中伤口得到治疗 用系列产品1)用抗生素清除病原体，2)促进健康的细胞环境 通过水凝胶涂抹，3)用皮肤替代物封闭伤口。因此，提议的产品 G4derm能够通过生物物理破坏G4Derm同时清除耐药病原体 细菌膜，同时促进宿主组织再生，而无需添加抗生素或生物制品。 本品可用于住院和门诊伤口护理，用于治愈感染药物的患者。 抗药性细菌，并减少美国每年因慢性疾病而进行的10万例截肢手术 伤口。 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：此快速通道计划将生成510(K)支持数据，证明安全和 G4derm作为一种同时对抗生素有毒性的抗菌细胞支架基质的疗效 耐药细菌菌株，同时保持有利于组织再生。当前产品使用 基于电荷的机制，在接触时溶解细菌膜，并具有促进作用的多孔结构 细胞浸润和细胞贴壁。 更广泛的影响：这项快速通道提案的更广泛影响将是一部小说的发展 抗菌机制，甚至可以消除感染伤口上的抗药性细菌菌株。 根据疾病控制和预防中心的报告，抗药性细菌将导致 每年有200万美国人受到严重感染，估计每年有2.3万人死亡。我们的 对抗抗药性细菌的能力正在减弱，新的潜在抗生素药物的流水线 变得越来越瘦。自1998年以来，只有9种新抗生素获得了FDA的批准，其中只有2种 结合了新的行动机制。因此，提议的产品提供了前所未有的 同时消除细菌与促进组织再生相结合。作为抗菌剂 机制是生物物理的，细菌不太可能对该产品产生抗药性。

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.