The organization that pioneered global positioning systems, voice recognition software, and ARPANET—the Internet’s earliest ancestor—is now putting research and development dollars to work creating innovative technologies to keep soldiers (and civilians) safe.
The Defense Advanced Research Projects Agency (DARPA) has collaborated with Arsenal Medical, Inc. to develop a revolutionary foam agent that can halt bleeding from severe internal abdominal wounds for up to three hours, with a survival rate of 72 percent. The Department of Defense (DoD) began the Wound Stasis foam project in 2010 in an effort to improve survival rates during the “Golden Hour:" the 60 minutes following an injury in which a wounded soldier is stabilized and moved to a treatment facility.
“Battlefield care is provided in austere, often hostile conditions, so the Department of Defense aims to transport injured troops off the battlefield and to appropriate healthcare facilities as quickly as possible," says Brian Holloway, DARPA Program Manager for the Wound Stasis System program, in an email to Healthline. "During the war in Iraq, DoD set a standard of one hour for this to happen; thus, the term ‘the Golden Hour.'
"Because approximately 50 percent of potentially preventable deaths from battlefield injuries are due to abdominal hemorrhage and delays in hemorrhage control during transportation to medical facilities, the need for rapid, far-forward hemorrhage treatments is great,” Holloway says.
According to the U.S. Army Institute of Surgical Research, this type of internal bleeding is the leading cause of potentially survivable deaths on the battlefield. This is, at least in part, due to the fact that internal wounds can’t be compressed with tourniquets or dressings. The Wound Stasis foam, which is designed to be administered by a combat medic, expands to fill a soldier’s intact abdominal cavity and can be easily removed by a trauma surgeon once the soldier reaches a hospital.
“Currently, there is no FDA-approved battlefield treatment that a medic can apply for these types of injuries; evacuation to a surgical setting is the only option. We created the Wound Stasis program to help increase treatment options and save lives,” says Holloway.
The foam itself is a polyurethane polymer administered directly into the abdomen via two injections. When the injected materials meet, they expand to more than 30 times their original volume, forming a solid mass of foam that contours to the patient’s internal organs without adhering to tissues or absorbing blood. The entire foam block can be removed by hand in less than one minute following an incision by a surgeon.
“We knew that the optimal product would need to be easily carried by medics on the battlefield. We knew that we would need a small amount of material that could fill the large abdominal cavity, but that could also be removable. Given these needs, it was intuitive to us that a foam material would be the optimal solution,” says Upma Sharma, Director of Material Science and Engineering at Arsenal Medical and Program Director for the Wound Stasis foam project in an email to Healthline.
“We took an extremely thoughtful approach when we began engineering the foam, knowing that it would have to be optimized over a number of independent variables," she added. "In total, we developed 1,200 foams so that we can control each critical parameter, including expansion and hydrophobicity.”
The Wound Stasis foam has performed so well on pig models of human injuries (increasing survival rates from eight percent to more than 70 percent) that DARPA has awarded Arsenal Medical a $15.5 million contract to perform Phase II testing. To date, DARPA has given Arsenal $22.5 million to develop the foam product.
“Work on the program will continue in pursuit of the technical requirements for FDA approval and program transition to end-user organizations,” says Holloway. “Our goal is to move as fast as possible in bringing this device to fruition.”
Researchers presented pre-clinical data on the foam treatment at the 2012 Annual Meeting of the American Association for the Surgery of Trauma in Kauai, Hawaii in September. Holloway is hopeful that the Wound Stasis foam, once approved by the FDA for use in human patients, will save the lives of many soldiers wounded in bomb blasts, as well as civilians who’ve suffered trauma in car accidents and elsewhere.
“Although DARPA's focus is on defense applications—particularly, in this case, improving survival rates for battlefield injuries—any such product, once commercialized, could impact civilian scenarios in which internal abdominal bleeding is likely to factor,” says Holloway. “It's highly plausible that such a product could become part of the toolkit for civilian first responders.”