WASHINGTON -- The U.S. Army Medical Materiel Agency, a subordinate organization of the U.S. Army Medical Research and Materiel Command, is supporting a pivotal clinical trial to test the safety and effectiveness of a self-expanding foam device that would stop massive intracavitary abdominal bleeding.
The device received an Investigational Device Exemption in early 2017 from the U.S. Food and Drug Administration. Throughout the next year, the device developer will select the clinical trial sites and complete pre-study approvals. The U.S. Army Medical Materiel Development Activity, which is also part of USAMRMC, will provide regulatory support for the project. The anticipated start date of the pivotal clinical trial is 2018.
"Right now, we are looking at this device as a potential stop-gap for patients awaiting surgical care," said Leigh Anne Alexander, USAMMA product manager. "This is not going to repair the injury but it could be a 'bridge to surgery,' keeping the patient alive long enough to give them a fighting chance at survival."
The device resembles a caulk gun that contains expandable foam designed to be injected into a patient by a trauma surgeon. The injector allows two separate chemicals to mix, causing the product's material to rapidly expand inside the abdomen to about 35 times its original volume. The foam is designed to expand around the patient's internal organs to stop bleeding and can be left inside the patient for up to three hours.
Army Medicine is focused on identifying and transitioning solutions currently in research and development that reduce the number of hemorrhage deaths in the military. Exsanguination, or bleeding to death, remains the most common cause of potentially survivable death to wounded warfighters.
A study published in the Journal of Trauma and Acute Care Surgery in 2012 reviewed nearly 5,000 battlefield fatalities from 2001-2011, categorizing them into two groups: non-survivable and potentially survivable. Of those that were considered potentially survivable deaths, more than 90 percent were related to hemorrhage. Of those deaths, more than 67 percent were related to truncal (trunk of the body) hemorrhage.
The wound stasis program from which this study derives began in 2010 at the Defense Advanced Research Project Agency. Under that program, DARPA collaborated with a private vendor, along with the Massachusetts General Hospital and the Harvard Medical School, to develop a novel, self-expanding polyurethane foam that rapidly compresses major abdominal bleeding due to trauma. The project transitioned to the Army in 2015 after promising animal study results.
"We are optimistic that this study will provide meaningful data and pave the way for future research," Alexander said.