MATERIALS MODIFICATIONS INC — Department of Defense SBIR Phase II: A14-048

Description

This SBIR Phase II project will evaluate and qualify the application of multifunctional biocompatible wound dressing developed in the Phase I for the controlled delivery of analgesic drugs to burn wounds. Burns are among the most painful and debilitating battlefield wounds faced by the US warfighter. Severe pain is felt during treatment and rehabilitation, especially during dressing changes, debridement’s, and skin grafting, and continues through long-term follow up. Opioid drug administration via oral or parenteral routes is the primary and most effective way of treating pain in burn patients. However, the systemic use of opioid medications in burn patients is complicated by the side effects such as tolerance, hyperalgesia, hemodynamic instability, respiratory depression, and dependence. Therefore, beside the systemic administration of analgesics, topical analgesics are required to control pain efficiently. Burn wounds can turn deadly when infection sets in. Thus, pain and infection are the two major complications associated with burn injuries. In the Phase I effort, a single patch device that can be used to alleviate pain and as wells as to prevent infection in burn injuries was developed. The Phase I in-vitro and animal model studies unequivocally demonstrated the technical feasibility of this burn wound dressing patch in pain control and antimicrobial applications. In the proposed Phase II study, efficacy of the patch will be demonstrated and validated the for pain control in an in-vivo model that replicates burn injury induced pain. Phase II study will include development, testing and demonstration of a prototype form of multifunctional wound dressing. The safety of the dressing material will be demonstrated with respect to biocompatibility and toxicity for securing regulatory approval for human use. The Phase II project will be followed by pre-clinical testing and validation of the topical dressing product by the US Army. Phase III will consist of clinical trials designed to test the safety and efficacy of the Phase II product in burn pain control.