With a $50,000 Commercialization Grant from the Medical Technology Enterprise Consortium (MTEC), biotechnology company KeriCure Medical has partnered with CNTR in developing a study protocol and proposal for a multi-center clinical trial for the company’s Field Shield Wound Dressing (FSWD) product. The proposal titled “Clinical Assessment of Large Surface Area Burn Treatment for Prolonged Field Care and Long-Term Care,” was submitted to the DoD FY22 Joint Warfighter program in July for a three-year up to $4.5M contract. A funding announcement is expected before the end of the year.
Organic chemist and company CEO, Kerriann Greenhalgh, PhD, explains that KeriCure’s advanced wound care product can effectively soothe, seal and protect multiple wounds in a simple point-and-spray hydrogel dressing. The proposed study will evaluate the efficacy of the FSWD spray as compared to a standard of care (SOC) silver dressing treatment in supporting wound healing and preventing infection and reducing the pain and discomfort of burn wounds and dressing changes.
This project will address the specific goals of the DoD for a large surface area burn wound therapy that can be used in pre-hospital settings by military medical providers or self-applied with minimal training required and can follow the patient throughout the continuum of care.
Thanks to advancements in protective gear and resuscitation techniques that have improved survival rates for those with severe injuries, emphasis has shifted to management of traumatic wounds in prolonged casualty care (PCC), where infections remain a major cause of morbidity and mortality.
“Combat-related injuries are at a high risk of infection, especially when left untreated for days,” Greenhalgh explained. “With Field Shield there is an opportunity to promote healing early and provide pain relief while not adding to the logistical burden in medical kits with a lot of additional supplies.” Early management and prevention of infection in burns to extremities also has the potential to prevent amputations that result from infections of large area burn wounds.
The proposed effort will provide a solution for the far-forward needs of warfighters to effectively treat and manage large surface area burn wounds in order to decrease morbidity and mortality rates, reduce infection rates, and promote wound healing in-theater for faster return to service. The inclusion of a civilian burn center in the trial will ensure that findings are relevant to both military and civilian patient populations.
If funded, the study will proceed under the direction of Dr. Leopoldo Cancio, Director of the U.S. Army Institute of Surgical Research/U.S. Army Burn Center, and Dr. David Herndon at the Joseph M. Still Burn Center at Doctors Hospital of Augusta, GA. The Coalition for National Trauma Research (CNTR) will provide study coordination and management, overseeing all aspects of the project at the two study sites.
MTEC is a nonprofit biomedical technology consortium that collaborates with the U.S. Army Medical Research and Development Command (USAMRDC) to accelerate the development of innovative medical solutions for Warfighters and, ultimately, all citizens. MTEC encourages partnerships among its 580 members, including small and large companies, nonprofits and academic research organizations. Both KeriCure Medical and CNTR are MTEC members.