In the heat of combat, every second counts to treat soldiers injured on the battlefield. A $1.5 million U.S. Department of Defense grant awarded to investigators at Colorado State University’s Translational Medicine Institute will fuel the development of a medical foam to meet this critical need.

Kirk McGilvray is an associate professor of mechanical engineering and associate director of the Orthopaedic Bioengineering Research Laboratory, where the development project is being housed. The investigative team also brings together collaborators, including veterinarians Lynn Pezzanite and Steven Dow of CSU’s Veterinary Teaching Hospital and Nicholas Alfonso, an assistant professor of orthopedics at the University of Colorado Anschutz Medical Campus. 

Inspiration for the foam’s development was born over conversation discussing the current protocol for antibiotic treatment.

“(We were) sort of brainstorming ideas to come up with a better way to deliver the antibiotics to the tissues in the wound, which are often very disrupted and revitalized,” Dow said. “We were just talking about, could you deliver it as a gel or a liquid? What would be the advantages or drawbacks? And then we kind of stumbled on, well, what if you could put the drugs in a foam?”

Other concerns with current antibiotic delivery methods include biofilm formation, a process in which bacterial pathogens colonize in host niches created by delivery agents.

“We’re developing something that has the potential to help a lot of people get back to living high quality lives, and that’s what we want. Because clinicians, they only have so many tools in their toolbox, and we just want to give them something else.” – Kirk McGilvray, mechanical engineering associate professor, OBRL associate director 

“Right now, the clinical protocol is (doctors) give (patients) systemic injections of antibiotics, and then they’re very scared of what’s called biofilm formation on (the) hardware,” McGilvray said. “So if you put a plate in to stabilize a broken leg, if bacteria starts to colonize on that, it’s very, very difficult to get off.”

Similarly, the battleground status quo requires injured soldiers to receive antibiotic administration through powder-form substances, such as vancomycin. While the method is effective, several factors that may affect a patient’s treatment are uncontrollable.

“You know, powder, as you imagine, if you throw it on something it can clump,” McGilvray said. “You don’t get even distribution, like, there’s problems with that. It’s not repeatable. So we said, ‘Hey, what about a volume-filling foam in which you can control the coverage, the release (and) kinetics?’”

Initial testing allowed the team to gather proof of conceptual data. These experiments allowed for a deeper understanding of the physical and molecular properties required to adequately deliver antibiotics in their target physical form.

“We ran some bench-top experiments,” McGilvray said. “We can generate the foam. We can understand the foam stability. We can produce it, and it doesn’t denature the therapeutics we’re delivering. It can give us a homogeneous volume-filling type product.”

The foam is composed of various chemical compounds specifically engineered to deliver antibiotics that are already present on the market.

“Our narrative is that it’s a biopolymer that has a long clinical record of biocompatibility and safety and other application spaces, and we are functionalizing that slightly different, and we’re using therapeutics that are on the market,” McGilvray said.

The foam, once injected into the wound, will be designed to remain in its original physical form until definitive care can be delivered to a patient.

“What happens is the foam breaks down as the bubbles pop (and) it coats and absorbs into the wound,” McGilvray said. “So it’s designed to stay in the wound, but it doesn’t become hard. It stays soft. … It coats the wound, delivering the topical or the therapeutic into there. And if needed — you know, you’re still not at the hospital — you can apply the foam again.”

This benchmark data was later submitted to the DOD and utilized to secure the most recent grant. With the new funding source, the experiment’s timeline has projected further into the coming years.

“Now we have about three years of funding, and the goal is hopefully, in a year from now, we have enough data to indicate, ‘Hey, … this really does have some real hard science legs to stand on to keep it moving forward,’” McGilvray said. “The ultimate goal is commercialization, to have a product that we can sell to the military, get into hospitals, you know, get to the patients.” 

While the military’s market interest is evident, McGilvray’s team will also work to identify other customer potentials in the private

sector in the coming year. 

“Obviously, the funding from the military indicates that they would be interested in the technology, which is a good size market,” McGilvray said. “But we’d also want to know, ‘Hey, is it better to get it in the hospital? Should this be in rural ambulances? Like, where can we get in the market the fastest and have the most impact?’ And then once you get into the market and kind of crack that door, it’s much easier to go with to add to your catalog of technologies that you can get out into the public space.”

Mechanical engineering graduate student Amelia Stoner has assisted the project’s research through her time at the OBRL alongside Ph.D. candidate Jacqueline Linn. She attributed her involvement to the growth of new product development skills.

“Through my time on this project, I have learned a lot about product development logistics and the importance of developing a technology that will address specific needs expressed by the people directly affected by a problem,” Linn said.

The compound also has potential usages in the veterinary field. The next move of testing will include a clinical trial to measure the effects on canine traumatic injuries. The similar biological makeup of humans and dogs will allow for more thorough evidence on the effectiveness of the delivery method.

“Dogs get a lot of the same types of infections that we do as people, and … they get treated with a lot of the same antibiotics,” Dow said. “That’s one of the reasons we think doing the studies of dogs is so important — because it will be so similar to what we would expect in a human.” 

McGilvray noted the collaborative effort required to develop such a product as a driving force behind his passion.

“I’m so passionate about this project because I get to work with really smart people,” McGilvray said. “As we think about some of these medical problems, they’re so complicated. I don’t believe you can solve them by yourself. You can’t live in a silo and attempt to come up with solutions for things that are so important.”

As development continues through the grant funding, McGilvray said his efforts are driven by the widespread application potential the product holds.

“We’re developing something that has the potential to help a lot of people get back to living high quality lives, and that’s what we want,” McGilvray said. “Because clinicians, they only have so many tools in their toolbox, and we just want to give them something else.”

Reach Katie Fisher at science@collegian.com or on Twitter @CSUCollegian.