Debridement of dead, damaged and/or infected tissue from thermal burn wounds and a certain subset of ischemic and necrotic diabetic foot wounds is a commonly utilized wound preparation modality before the application of fillers, dressings or grafts. The existing wound debridement techniques have serious issues such as invasiveness and impreciseness, painfulness, removal of appreciable healthy areas along with dead tissue, unacceptably slow procedure time and a greater opportunity for secondary infection onset due to procedural trauma or due to deeper embedment of surface bacteria. Clearly since over 5 million debridement procedures are conducted per year in the USA alone, the majority of them being surgical in nature, this is an area of high medical concern. Therefore, the introduction of a new debridement modality that does not have the limitations of the existing methodologies is warranted and necessary to cause a paradigm shift for a highly sustained and positive impact on this field. This proposed Phase I STTR effort which involves a collaborative partnership between Lynntech, Inc. and Beth Israel Deaconess Foot Center at Harvard Medical is specifically designed to address the above challenge. In this effort, we propose a new wound debridement technology, consisting of a topical gel which is specifically engineered to selectively latch onto necrotic tissue areas and provide nanoabrasive action while deswelling to gently remove these areas from the wound bed. In addition, the gel deswelling is also expected to provide the additional benefit of exudate entrapment and removal to leave behind a clean wound bed ready for further treatment. We hypothesize that the unique nature of this type of minimally invasive wound debridement technology should provide the greatest benefit to the preparation of ischemic and necrotic chronic wounds as well as thermal burn wounds. During this Phase I STTR effort, our overall goal is to provide proof-of-concept for the feasibility of this wound debridement technology by pursuing the following specific aims, namely (1) prepare and characterize wound debridement gels, (2) develop a comprehensive theoretical model to explain the gel volume phase transition, (3) perform ex- vivo cytotoxicity evaluation to demonstrate the biocompatible nature of the gels, and (4) perform preliminary animal studies utilizing normal and diabetic rabbit models to demonstrate that the hydrogels are useful for wound debridement. The successful completion of these specific aims should demonstrate ample feasibility of this new wound debridement concept, and will allow us to plan more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. In addition, during the Phase II effort, we may further improve the basic wound debridement gel technology platform by including hydrogel phase transition triggered slow release of enzymatic debridement promoting agents. The eventual commercial availability of such a novel wound debridement technology is likely to sustain high positive impact for the patient populace that requires wound debridement.
This proposed study will sustain high positive impact in the field of thermal and chronic wound healing and is specifically devised to provide proof-of-concept for the feasibility of our stimuli responsive nanoabrasive wound debridement gel technology. The study if successful will also sustain high commercial impact in the medical wound preparation marketplace as it is expected to be a minimally invasive wound debridement product. The potential benefits to the millions of patients undergoing debridement procedures annually are numerous including lowered pain, faster wound healing times, better healing outcomes from both a physiological as well as a cosmetic standpoint and lowered cost of treatment.