GEL4MED, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

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 to of patients undergoing surgery in the United States and accounting for approximately of deaths due to health care associated infections These infections have resulted in million excess hospital days and close to $ 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 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 G Surg the proposed product overcomes current limitations by preventing eliminating infection through a unique mechanism of action that is broad spectrum antibacterial G Surg takes advantage of charge composition to exert toxicity against Gram positive and negative bacteria including antibiotic resistant strains Furthermore G Serg 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 Through in vivo safety studies demonstrate biocompatibility of G Surg during incisional wound healing Specific Aim Through in vivo efficacy studies demonstrate G Surgandapos s ability to clear bacteria infected abdominal incisional wounds In SBIR Phase II we will validate G Surg 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 Surgical Site Infections are the second most common type of health care associated infection occurring in to of patients undergoing surgery in the United States Current prevention strategy which involves the use of systemic antibiotics does not adequately reduce the risk of surgical site infections and is plagued by inefficacy against multi drug resistant organisms In light of this we propose to develop a safe and easy to use antimicrobial hydrogel that kills both gram positive and negative bacteria including multi drug resistant organisms to prevent surgical site infections without the use of antibiotics