Ruggedized Spray on Antimicrobial Wound Dressing for Treatment of Multiple Sulfur Mustard-Induced Dermal Injuries in Theater to Mitigate Infection, Pain and Promote Healing

Field Shield Wound Dressing (FSWD) is a novel wound dressing that takes an innovative approach to addressing major wounds, both in prolonged field care and throughout the continuum of care. It is the first wound dressing to combine an effective broad spectrum antimicrobial (nanosilver) with a local anesthetic (lidocaine) in a simple to apply point-and-spray wound dressing. A patented polyacrylate nanopolymer base for the dressing allows it to conform over any size or shape wound and stretch and move with the body over areas such as elbows and knees, which is a unique function of the KeriCure Medical wound dressings. This capability provides ease of movement for the injured Warfighter, allowing evacuation of the injured without restrictions from the wound dressing. In regards to sulfur mustard (HD) related dermal injuries, with the potential for mass exposures with multiple injuries occurring at once, having a topical wound dressing that could be easily applied with minimal technical training to self or buddy administer is critical to providing immediate care that may reduce prolonged exposure complications. Field Shield is presented here as a water based, hydrogel style wound dressing that can soothe the HD exposed tissue and resulting inflammation, form a seal over the damaged skin, provide a broad spectrum antimicrobial to kill any contaminants embedded in the wound during the exposure event, and provide some numbing and local pain relief. The dressing can help to ensure the injuries stay free of bacteria and contamination, and will trap and maintain moisture below the clear polymer barrier to prevent fluid loss for the wounds so they can maintain the appropriate environment for healing. The objectives of this Phase I effort will establish a clear strategy for Phase II efforts that are in line with the FDA’s expectations for a 510(k) submission of a wound dressing with indications for management of HD dermal injuries. The work proposed here will establish working relationships with labs that can carry out preclinical studies involving HD and solidify a plan for the studies that will provide the basis for FDA 510(k) clearance. The specific objectives of Phase I are as follows: Objective 1. Generate a detailed regulatory plan to obtain FDA 510(k) clearance for Field Shield Wound Dressing, with indications for use on HD dermal injuries. Objective 2. Obtain confirmation from the FDA via pre-submission meeting that the regulatory plan is acceptable to obtain an HD dermal injury indication for Field Shield Wound Dressing. Objective 3. Formalize a relationship with a laboratory or multiple laboratories to perform preclinical HD dermal wound studies based on the study outlines established in Objective 2 with the FDA.