Flowable antimicrobial skin scaffolding matrix that promotes regeneration

 描述（由申请人提供）：该I期SBIR提案的目的是测试抗菌组织支架水凝胶基质在消除感染性细菌病原体和促进伤口再生方面的可行性。由于多药耐药微生物（MDRO）的迅速增加，预防和治疗伤口感染和再生变得越来越不有效。Pada等人（2011）最近的一项研究报告称，与无感染的患者相比，MRSA感染伤口患者住院期间死亡的可能性高10.2倍，住院时间长4.6倍，住院费用高4倍。在MRSA（多重耐药金黄色葡萄球菌）中存活下来的患者经常要在医院呆上几个月，并忍受反复手术切除感染组织。1974年，2%的葡萄球菌感染是MRSA。到了1995年，这个数字已经攀升到22%，现在已经超过60%，而且还在上升。申报产品将通过以下两种方式治疗伤口：（i）通过广谱抗菌的独特作用机制预防感染;（2）通过在支架基质内提供细胞附着位点促进组织再生。此外，申报产品的凝胶制剂使其易于流动，并易于符合独特的伤口形状和深度，因此任何医疗保健专业人员均可快速给药。为了确定可行性，我们提出了以下两个具体目标：具体目标1）在感染金黄色葡萄球菌（S. aureus)具有良好的抗菌活性。里程碑：显示S的消除。具体目的2）证明水凝胶促进猪背部全层切除伤口愈合的体内功效。里程碑：在第14天显示伤口愈合加速。在SBIR第II阶段，我们将在感染伤口愈合猪模型中验证水凝胶，建立GMP生产，并执行GLP研究，为我们的FDA申报做准备。

 DESCRIPTION (provided by applicant): The goal of this Phase I SBIR proposal is to test the feasibility of an antimicrobial tissue scaffolding hydrogel matrix in eliminating infecting bacteril pathogens and promoting wound regeneration. Preventing and treating wound infections and regeneration are becoming less effective due to the rapid rise in Multi-drug Resistant Organisms (MDRO). A recent study by Pada et al. (2011) reported that patients with MRSA-infected wounds were 10.2 times more likely to die during their hospitalization, had 4.6 times longer hospitalization, and incurred 4 times higher hospitalization costs when compared to patients without infection. Patients who do survive MRSA (multidrug-resistant Staphylococcus aureus) often spend months in the hospital and endure repeated surgeries to cut out infected tissue. In 1974, 2% of staph infections were MRSA. By 1995, the number had climbed to 22%, and now is over 60% and still rising. The proposed product will treat wounds by both (i) preventing infection through a unique mechanism of action that is broad spectrum antibacterial, and (2) it will promote tissue regeneration by providing cell attachment sites within the scaffolding matrix. Additionally, the gel formulation of the proposed product allows it to be flowable and conform to unique wound shapes and depths easily, so it can be administered quickly by any healthcare professional. To establish the feasibility, we propose the following two specific aims: Specific aim 1) Demonstrate the therapeutic in vivo efficacy of the product to eliminate infection from a wound in a mouse model infected with Staphylococcus aureus (S. aureus). Milestones: Show elimination of S. aureus from wounds to 99.9% or below as quantified by bacterial titers Specific aim 2) Demonstrate the in vivo efficacy of the hydrogel to promote healing of full-thickness dorsal excisional wounds in swine. Milestones: Show accelerated wound healing by day 14. In SBIR Phase II, we will validate the hydrogel in an infected wound healing swine model, establish GMP manufacturing, and execute GLP studies in preparation for our FDA submission.