About 200,000 of the HemCon bandages, developed with the help of the Army's medical laboratory and the recipient of $29 million in Army purchase contracts and research grants, are to be distributed to every soldier in Iraq and Afghanistan within the next few months.
Army leaders, who deemed the bandage one of their "Top 10 Greatest Inventions" for 2004, call it a revolutionary step in treating severe hemorrhage, the leading cause of preventable death in combat. It is among the few nonsurgical methods developed to stop bleeding that is too severe to be controlled with a tourniquet or gauze.
Yet even as the Army's purchase order approaches 60,000 units a month and the HemCon bandage becomes increasingly prevalent throughout the military, doubts are rising from inside and outside the service that the bandage works as well as advertised - or at all.
Scientists working for the Navy have begun to question claims that HemCon possesses a unique blood-clotting ability, saying their studies show the dressing to be only slightly more effective than gauze. Some soldiers in Iraq say they have been discarding the $89 dressings unused because they don't consider the rigid bandages practical for combat injuries. One of the Army's studies, conducted last year and published in July, says the bandages are prone to slough off after an average of 49 minutes, allowing patients to bleed again.
Outside scientists say another product stops bleeding far more quickly and effectively: a granular substance called QuikClot, which costs the military $9.85 per bag.
Army medical officials acknowledge that HemCon isn't perfect, but they say it is the closest they've come to finding a safe treatment for the types of massive bleeding that have been killing wounded American soldiers for centuries. While the bandage might fall off, soldiers in modern combat are likely to be treated by a surgeon long before that happens, and the dressing can help keep them alive in the critical minutes after an injury, they say.
They agree that QuikClot works but say it can also cause burns - severe burns, according to the findings of the Army's medical laboratory at Fort Sam Houston in San Antonio. They have advised Army soldiers to avoid QuikClot and to await the stepped-up delivery of HemCon instead.
Officials with the Navy, the Marine Corps and the Air Force, meanwhile, consider that advice misguided. They have issued QuikClot to all of their combat forces, saying the potential for burns is an acceptable risk. Many of the Army's combat troops, having reached the same conclusion, are buying QuikClot for themselves despite the Army's recommendations.
Leaders of the Army's 101st Airborne Division ordered 4,000 packages of QuikClot when the unit began its second deployment to Iraq this fall. At a recent training session at Fort Dix, N.J., Army instructors urged soldiers headed for Iraq to add QuikClot to their combat gear even if they had to buy it themselves.
"What's worse, giving your buddy a little burn while you save his life or doing nothing and letting him die?" said Sgt. 1st Class Gregory Wilson, an Army medic who has trained thousands of soldiers at Fort Dix, the military's largest mobilization center. "Go back, talk to your supply folks and tell them to get this stuff for you," he told a class of soldiers deploying to Iraq and Afghanistan in June. "And don't let them tell you it's not available. Be aggressive. It can save your life."
Civilian doctors and researchers say the disagreements among Army and Navy scientists illustrate the complexities and the perils of operating on the leading edge of military medicine. Both services have pressed their preferred hemostatic agents into use faster than usual because they are desperate to give wounded soldiers and Marines the benefits of cutting-edge technologies, even as those benefits are still being explored and defined.
"We determined it was best to simply pursue other markets," said John Vournakis, a research scientist at the Medical University of South Carolina and executive in a company developing a trauma dressing called the Rapid Deployment Hemostat. "We've really not had a very happy and positive experience with the military."
"If the Army didn't invent it, they don't want it. I think that about sums it up," said Bob Harder, president and founder of the medical supply company H&H Associates, which manufactures and distributes products primarily to the Marine Corps and law enforcement agencies.
Medical officials in the Army say the perceived shortcomings of HemCon have been largely a problem of training. Their tests, performed on pigs at the Army's medical laboratory in San Antonio, showed HemCon to be extremely effective at stopping severe bleeding when properly applied, according to reports of the laboratory's studies published the past three years in the Journal of Trauma.
A survey of combat medics in Iraq also indicates the dressing is saving lives when used by soldiers who are trained to apply the dressing and maintain adequate pressure with their hands or another dressing, Army medical officials say. They are sending instructors and training materials to combat units to ensure soldiers understand when to use the battle dressing and how to apply it properly
"It has no known side effects, the performance is amazing in every study we've developed and the reports from people who actually use the product have been positive," said Col. John B. Holcomb, commander of the Army's Institute of Surgical Research. "There's no reason to field an alternative that has known complications."