Project Number: 6054-41430-009-002-I
Project Type: Interagency Reimbursable Agreement
Start Date: Jul 5, 2022
End Date: Sep 30, 2023
The USDA/USMC effort seeks to develop hemostatic and antibacterial dressings suitable for prolonged battlefield care during Expeditionary Advanced Base Operations. Moreover, the need for domestically produced dressings due to a compromised supply chain brought on by near-peer conflict has been identified by the Defense Health Agency and the USMC as per President Biden's Proclamation on supply chains. Thus, the objective of this effort is to develop and deploy a family of affordable, US sourced and manufactured cotton based wound treatments, to include hemorrhage control, wound protection, anti-infective, and advanced wound care products for burns and slowly healing wounds. US Department of Agriculture, Agricultural Research Service (USDA/ARS), through a Cooperative Research and Development Agreement has developed a portfolio of cotton based wound healing technologies that are in various stages of development and are ready to enter the engineering and manufacturing development phase of capability development. The DHA, Marines and USDA agree to work collaboratively on any Cooperative Research and Development Agreements (CRADA) that will be needed to execute the scope referenced. Any specific language or special information needed will be memorialized on the execution document, 7600B.
FY 22/23 Addresses: 1) Develop manufacturing and treatment processes that will be adopted for commercialization of hemorrhage control and antimicrobial dressings. This will involve: identification of a suitable cotton-based substrate commensurate with large scale production and volume requirements of industry, transfer of hemorrhage control and antimicrobial finishing chemistries to the cotton fabric substrate, and demonstration of the pilot scale processing. 2) Extensive functional and performance tests on lead prototype wound dressings produced from pilot scale to demonstrate the efficacy and safety of the product prototypes will be performed at Virginia Commonwealth University Medical College of Virginia under VCU/IACUC guidance protocols for animal use. The principal in vivo study required to demonstrate hemorrhage control efficacy will be the Army pig lethal femoral injury model. In addition product safety will be assessed with the Army pig lethal femoral injury model and subsequent examination of vasculature tissue for systemic thrombosis. 3) Similarly antimicrobial/antiviral dressing prototypes will be developed subsequent to demonstration of their efficacy in the military ESKAPE model (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter) for gram negative and positive antibacterial efficacy. 4) Materials that have potential as a combination product with cotton based scaffolds will be developed as a novel dressing for improving existing therapies and reparative processes at cutaneous and other wound sites. In cooperation with Obatala Sciences decellularized adipose tissue will be formulated with cotton-based scaffolds to investigate improving existing therapies and reparative processes at cutaneous and other wound sites. This component of the family of dressings targeted to field care relates to care of burn wounds. Excisional wounds in mice are one of the most commonly used wound healing models, considered to resemble acute clinical wounds. The model allows the investigation of hemorrhage, inflammation, granulation tissue formation, re-epithelialization, angiogenesis and remodeling. In this study, the full thickness excisional wound model will be used with a splinting ring that tightly adheres to the skin around the wound, preventing contraction. This model will evaluate the efficacy of the cotton and cotton/decellularized adipose tissue derived hydrogel mix to promote wound healing. 5) Deliverables will consist of: Hemorrhage control and antimicrobial prototypes with scalable and commercial manufacturing capability and in line with ARS/USDA patent application assignments for licensing. Utilization of ARS/USDA patent application assignments will align the technology and functional properties of the dressings needed for commercial licensing and commercialization. Other deliverables as jointly determined by the USDA and USMC include publications, new patent applications and transfer of the technology through military and private industry venues.