Surgical Wound Closure Matrices for the Prevention of Superficial Incisional SSI

用于预防浅表切口 SSI 的手术伤口闭合基质

• 批准号: 9255779
• 负责人: Manav Mehta
• 金额: $ 22.39万
• 依托单位: GEL4MED, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-01 至 2019-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9255779
• 关键词: Abdomen; Accounting; Adherence; Amino Acids; Animal Model; Animals; Anti-Bacterial Agents; Antibiotic Resistance; Antibiotics; Arginine; Bacteria; Binding; Biological Sciences; Cells; Cellular Infiltration; Cessation of life; Characteristics; Charge; Collagen; Complex; Control Animal; Cytoskeleton; Delaware; Dermal; Diabetic wound; Dose; Drug Delivery Systems; Drug toxicity; Extracellular Matrix; Family suidae; Fiber; Gel; Gentamicins; Geometry; Goals; Guidelines; Health Expenditures; Healthcare; Histopathology; Hospitals; Hour; Human; Hydrogels; In Vitro; Infection; Infection prevention; Infectious Skin Diseases; Inpatients; Lead; Legal patent; Length of Stay; Light; Measures; Membrane; Methods; Microbial Biofilms; Modeling; Molecular Conformation; Molecular Structure; Oligopeptides; Operative Surgical Procedures; Patients; Peptides; Perioperative; Pharmaceutical Preparations; Phase; Prevention; Prevention strategy; Procedures; Property; Prophylactic treatment; Rights; Risk; Safety; Site; Small Business Innovation Research Grant; Sterile coverings; Sterility; Surgical Wound Infection; Surgical incisions; Surgical wound; Techniques; Technology; Testing; Therapeutic; Thick; Time; Tissues; Topical Antibiotic; Toxic effect; Treatment Efficacy; United States; Universities; Vancomycin; Work; Wound Healing; antimicrobial; base; biomaterial compatibility; cost; design; efficacy study; extracellular; healing; in vivo; killings; multi-drug resistant pathogen; nanofiber; nanosized; payment; prevent; resistant strain; response; safety study; scaffold; tissue regeneration; wound; wound closure

The goal of this Phase I SBIR proposal is to test the feasibility of an intra-tissue antimicrobial surgical wound matrix in the prevention of superficial surgical site skin infections. Surgical Site Infections (SSI) are the second most common type of health care–associated infection (HAI), occurring in 2% to 5% of patients undergoing surgery in the United States, and accounting for approximately 2.0% of deaths due to health care- associated infections. These infections have resulted in 3.7 million excess hospital days, and close to $10 billion in health care expenditure annually. Current methods for SSI prevention include preoperative and perioperative systemic antibiotic use, perioperative application of antibiotic drug-containing (gentamicin, vancomycin) dressings or beads, and strict adherence to OR sterile technique procedures. The efficacy of systemic antibiotic use is significantly reduced by the requirement to adhere to carefully timed drug delivery due to short half-lives of less than 2 hours. The use of topical antibiotics has been challenged by the limited efficacy. Both systemic and topical antibiotic uses are plagued by inefficacy against multi-drug resistant organisms (MDROs). G4Surg, the proposed product overcomes current limitations by preventing/eliminating infection through a unique mechanism of action that is broad spectrum antibacterial. G4Surg takes advantage of charge composition to exert toxicity against Gram- positive and -negative bacteria (including antibiotic resistant strains). Furthermore, G4Serg relies only on sequences for antimicrobial charge ratio, and therefore is cell friendly, non-inflammatory, and nontoxic. To establish feasibility for the treatment of diabetic wounds, we propose the following two specific aims: Specific Aim 1: Through in vivo safety studies, demonstrate biocompatibility of G4Surg during incisional wound healing. Specific Aim 2: Through in vivo efficacy studies, demonstrate G4Surg's ability to clear bacteria infected abdominal incisional wounds. In SBIR Phase II, we will validate G4Surg efficacy in infected wound healing in a large animal model, test a wider range of bacterial strains in planktonic and biofilm forms, and execute GLP studies for our FDA submission.

第一阶段 SBIR 提案的目标是测试组织内抗菌手术的可行性 伤口基质预防浅表手术部位皮肤感染（SSI）。 是第二常见的医疗保健相关感染 (HAI) 类型，发生于 2% 至 5% 的患者 在美国接受手术，约占因医疗保健导致的死亡的 2.0% 这些感染导致住院时间延长 370 万天，损失近 10 美元。 每年医疗保健支出达 1 亿美元。 目前预防 SSI 的方法包括术前和围手术期全身使用抗生素、 围手术期应用含抗生素药物（庆大霉素、万古霉素）的敷料或珠子，并严格 遵守手术室无菌技术程序的情况会显着降低全身抗生素使用的效果。 由于半衰期短于 2 小时，因此需要严格定时给药。 局部抗生素的使用受到全身和局部抗生素使用效果有限的挑战。 受到拟议产品 G4Surg 对多重耐药微生物 (MDRO) 无效的困扰。 通过独特的作用机制来预防/消除感染，从而克服当前的局限性 G4Surg 利用电荷成分对革兰氏菌发挥毒性。 阳性和阴性细菌（包括抗生素耐药菌株）。此外，G4Serg 仅依赖于 序列用于抗菌电荷比，因此对细胞友好、非炎症且无毒。 为了确定治疗糖尿病伤口的可行性，我们提出以下两个具体目标： 具体目标1：通过体内安全性研究，证明G4Surg在切开过程中的生物相容性 伤口愈合。 具体目标2：通过体内功效研究，证明G4Surg清除感染细菌的能力 腹部切口。 在 SBIR II 期中，我们将在大型动物模型中验证 G4Surg 在感染伤口愈合中的功效，测试 浮游和生物膜形式的更广泛的细菌菌株，并为我们的 FDA 执行 GLP 研究 提交。