Phase II Amount
$1,095,660
Background. The long-term goal of this project is to establish an enabling antimicrobial technology aimed at providing a range of anti-infective materials for use by the military. Building on prior accomplishments from research, the goal under this award is to develop an affordable, effective antimicrobial gauze for burn wounds that reduces the frequency of dressing changes in prolonged field care environments. iFyber, the lead company for this effort, will achieve this goal by developing a copper-based antimicrobial dressing with hydrogel properties. Copper is known to limit healthcare associated microbial infections and provide a more cost-effective solution to silver. Development of this dressing will entail production of various prototype dressing materials that will be down-selected to a final product using various laboratory tests of antimicrobial and anti-biofilm activity, and safety that will eventually cleared by the FDA for use as a military standard issue wound dressing, which will ultimately be introduced to civilian populations. Major accomplishments from previous research include lab-scale development of a robust copper coating method for cotton fibers that can be tuned with respect to copper loading for both antimicrobial efficacy and biocompatibility, and identification of copper coatings with potent antimicrobial properties with limited cytotoxic potential as indicated from in vitro and in vivo studies. iFyber intends to combine this technology with commercial hydrogel fibers to develop a low cost antimicrobial combat burn gauze comprising highly functional fibers within a nonwoven design. Study Design. Aim 1: iFyber will use Design of Experiments (DOE) methodology to systematically optimize the copper coating and fiber production resulting in hydrogel dressing prototypes that will be tested in in vitro and ex vivo antimicrobial, anti-biofilm and biocompatibility studies (Aim 2) to down select to best performing prototypes. Lead candidates will be further down selected using in vivo efficacy, wound healing and safety studies (Aim 3) and a lead candidate will be marked for scale up production in subsequent efforts. Aim 2: Candidate antimicrobial burn dressings will be tested within a battery of in vitro and ex vivo model systems for antimicrobial and anti-biofilm activity and biocompatibility. The main criteria for advancing towards lead candidate prototypes will be log reduction in a microbial challenge, the cytotoxic potential as assessed in cell culture. Aim 3: Advance in vivo efficacy and wound healing in sine burn models will be used to further down select prototype dressings in the presence and absence of a microbial challenge. Dressings will also be studied using a battery of FDA-recognized ISO-10993 in vitro and in vivo experiments to assess their potential safety. Products from the studies planned in Aim 2 and Aim 3 will be used to select a lead candidate for future efforts.
