Production of a dissolvable hydrogel-based wound dressing for second degree burns

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ABSTRACT. This proposal describes the development of the HydrAid Burn Dressing—a novel hydrogel-based wound dressing that absorbs exudate, protects the wound from bacterial infection and can be easily removed from the surface of 2nd degree burns via dissolution thereby averting trauma to the wound and pain to the patient. Burns are one of the most common and devastating forms of trauma. Millions of patients suffer burn-related injuries each year and, while severe burns are less frequent, these patients may suffer disability, disfigurement and psychological damage during and even after treatment. Changing of burn dressings is reported to be the most painful time (after the initial burn) and opioids are the mainstay of pain mitigation for burn patients. The duration of a burn dressing change in a typical injury requiring ICU/OR-level care is often 60+ minutes with induction of general anesthesia and can extend to more than three hours. At present, commercially available dressings adhere to the wound surface so that dressing changes lead to traumatization of newly formed tissues, delayed healing and, in 2nd degree burns where nerve endings are still intact, excruciating pain for the patient. Our solution to this problem is the HydrAid Burn Dressing. The HydrAid dressing is composed of an amine- terminated dendron and a bifunctional NHS-activated PEG containing an internal thioester that react with each other to form a thioester-linked hydrogel dressing that can be subsequently dissolved by exposure to an aqueous thiol solution via a thiol-thioester exchange mechanism. Our successful Phase I work demonstrates: 1) our ability to synthesize the HydrAid components; 2) absorption and swellability with exudate mimics; 3) lack of in vitro cytotoxicity or macrophage activation; 4) on-demand removal by dissolution in vivo on a 2nd degree burn by application of a cysteine methyl ester solution; 5) prevention of bacterial infections in 2nd degree burns in vivo; 6) comparable and trending superiority of healing compared to traditional bandages; and, 7) easy “spray- on/spray-off” use in covering the intricate surfaces, digits, and webbing of a human hand. The ultimate goal of the proposed project is to obtain 510(k) clearance for the HydrAid Burn Dressing. Aligned with this goal is the completion of key Go/No-Go milestones in four primary product development categories: 1) Manufacturing, 2) Bench and animal testing, 3) Human Factors (non-clinical) usability testing, and 4) Regulatory affairs. Aim 1: Transfer production methods to Contract Manufacturing partners (PCI Synthesis) and perform an initial bottling production run (Power Container Corp.) to provide finished product for evaluation in Aims 2 and 3. Aim 2: Confirm HydrAid Burn Dressing superiority to conventional dressings in large surface area burns and perform relevant ISO 10993 safety and biocompatibility testing. Aim 3: Conduct Human Factors and non-clinical usability testing and develop labeling, including Instructions for Use. Aim 4: Execute regulatory strategy, including: labeling and usability testing strategy, pre-submission meeting with the FDA, and 510(k) submission to the FDA. Successful completion of these aims will position Ionic Pharma to begin production, marketing and sales of HydrAid.