Burns with associated other traumatic injuries, such as traumatic brain injury, blast injuries, fractures, injuries to the skin, muscle, and bone, occur in approximately one-third of wartime injuries. Combined burn/trauma injuries are problematic because they are painful and consume numerous resources, including dressing supplies, equipment, narcotics, and personnel. Pain associated with the wounds incapacitates the injured Soldier at the point of injury, and the narcotics used to treat pain decrease the Soldier’s physical and mental function. A nonnarcotic dressing that can be immediately applied to a burn wound (or any other traumatic wound) and left in place for 5-7 days that decreases pain both immediately and for 5-7 days would conserve valuable resources (narcotics, dressings) and improve injured Soldier capabilities, particularly during prolonged field care situations. Lidocaine is a local anesthetic that is usually injected to decrease pain. When used topically on a large wound, lidocaine can cause neurologic (seizures) and cardiac (arrhythmias) complications. Wounds can be injected with lidocaine, but this requires a sterile environment and supplies, and the effects are short-lived.

We have utilized our expertise in wounds and nanotechnology to develop a wound dressing that consists of lidocaine bonded via a nanoparticle to dried tilapia skin (long-acting lyophilized nanoparticle anesthetic tilapia dressing, or NPD). The nanoparticle controls the release of lidocaine to the injured tissue to control pain yet minimize toxicity, while the tilapia skin, which improves wound healing, serves as a protective dressing. The dried tilapia skin is light, can be easily carried, and can be easily reconstituted at the time of use by adding water. This would decrease acute and long-term pain as well as promote wound healing.

The purpose of this proposal is to determine the pharmacokinetics (drug absorption and clearance) of various doses of lidocaine in the NPD and to determine the optimal safe amount of lidocaine to incorporate in the nanoparticle dressing using a pig model. This application therefore addresses the FY21 MBRP IDA Focus Area for development of therapeutic interventions for burn injury in the polytrauma patient to improve Service Member outcomes by addressing gaps in injured combatant wound care and pain control at the point of injury. The project will benefit burn-injured Service Members by controlling pain immediately and in the days post-injury while still maintaining battlefield readiness. The general public would benefit from this dressing, as it could be used in the field by paramedics for a burn or any traumatic wound to immediately control pain. The dressing could also have applicability in the hospital for painful wounds ranging from burns and skin graft donor sites to acute and chronic wounds. The clinical benefits are potential improvements in pain control, infection prevention, and wound healing. The risk is toxicity of lidocaine (hence, this study) and wound infection. This project is a crucial step in bringing the NPD to clinical use, as it provides safety and dosing data that are essential prior to applying the dressing clinically. The next step in the development of this dressing would be a study comparing pain control, wound healing, infection, and scarring between the NPD and current dressing care. Further clinical trials and approval by the Food and Drug Administration would be the final step in the process. The NPD could fundamentally change wound management at the point of injury and throughout the continuum of care.