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.

本I期SBIR提案的目标是测试组织内抗菌手术的可行性