Army’s Costly Battlefield Bandage Raises Questions

The U.S. Army is launching a multimillion-dollar campaign to equip all of its combat troops with a futuristic bandage designed to stop massive bleeding from battlefield injuries, despite doubts about its effectiveness and the development of a new, cheaper product that many scientists believe works better.

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 its “Top 10 Greatest Inventions” earlier this year, 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 questioned 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, Styrofoam-like bandages practical for combat injuries.

One of the Army’s own 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.

And 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 say that it is the closest they’ve ever come to finding a safe treatment for massive bleeding. Although the bandage might fall off eventually, 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 that it can also cause severe burns. 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 and have issued QuikClot to all of their combat forces, saying that the potential for burns is an acceptable risk. And many of the Army’s combat troops, reaching the same conclusion, are buying QuikClot for 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, as he trained deploying soldiers at Ft. Dix, the military’s largest mobilization center.

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.

But civilian researchers in the field of hemorrhage control also say the debate has become so politically charged, and so clouded by institutional pride, that several of them have stopped cooperating with the military’s research laboratories.

“We determined it was best to simply pursue other markets,” said John Vournakis, an executive in a company developing a trauma dressing called the Rapid Deployment Hemostat.

“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.

Medical officials in the Army say that 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 last three years in the Journal of Trauma.

They are sending instructors and training materials into combat units to ensure that soldiers understand when to use the unique 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.”

But Holcomb’s counterpart in the Navy has reached a different conclusion.

“HemCon doesn’t work,” said Navy Capt. Peter M. Rhee, director of the Navy Trauma Training Center in Los Angeles and former head of the military’s research laboratory in Bethesda.

“I’ve tried every one of these products, many times, on many different kinds of wounds,” Rhee said. “For big-time bleeding -- and that’s what we’re really worrying about here -- HemCon doesn’t work.”

For much of the late 1990s, Army researchers, in cooperation with the American Red Cross, worked to develop a bandage that was treated with human blood proteins. The Red Cross bandage, which showed a remarkable ability to coax human blood into forming a solid and stable clot, was distributed to Special Forces troops in Afghanistan as part of a large-scale trial in 2002.

But the trial was halted after one reported use -- a successful one -- and the program was mothballed, because the $1,000-apiece dressing proved too unstable for mass production and too unconventional for easy approval by the Food and Drug Administration.

Around the same time, scientists at the Oregon Medical Laser Center in Portland, Ore., developed a unique process of crystallizing a derivative of shrimp shells called chitosan to form a flexible pad that seemed to have superior blood-clotting qualities. Army researchers flew to Oregon to watch the scientists press their chitosan pads onto bleeding pig arteries and were impressed by the results.

The scientists formed HemCon and got expedited approval from the FDA in November 2002, then began delivering the dressing in small batches just as troops were preparing for the invasion of Iraq in early 2003. As of today, the company has received about $29 million in grants and purchase orders from the Army, its sole customer.

The Marine Corps, meanwhile, had already committed to QuikClot, an inorganic mineral made by Z-Medica Corp. in Wallingford, Conn., that is poured into a wound. In animal studies at the military’s research laboratory in Bethesda, sponsored by the Office of Naval Research, QuikClot saved the life of every animal it was applied to.

But from its earliest studies QuikClot displayed an obvious drawback: its tendency to create heat when mixed with a liquid, such as blood. The Army and Navy have never been able to agree on the extent of the product’s potential danger.

When tested on pigs in the Army’s labs, QuikClot got hot enough to scorch skin and kill tissue around the wound, and it required the scientists to wrap their hands in surgical tape and two pairs of gloves. In the Navy’s studies, it barely got hot enough to cause discomfort.

Even when the laboratories conducted virtually identical experiments -- mixing equal amounts of blood and QuikClot together in a beaker or petri dish -- they reported vastly different results. Army scientists recorded a peak temperature of 140.4 degrees Celsius, well above the boiling point of water, while scientists working for the Navy measured 48 degrees Celsius, cooler than the hot water from most household faucets.

The Army issued a warning to its service members that QuikClot can cause burns and continued buying HemCon.

By January of this year, when the U.S. Central Command issued a directive that every American service member should carry one of the two agents in combat, the Marine Corps was fully outfitted with QuikClot, while Army units awaited the gradually increasing shipments of HemCon.

The Air Force decided in April to issue QuikClot to all of its airmen and other combatants, after concluding that, “in practice, burns were not really a problem that seemed to change the management of the patient,” according to Lt. Col. Joe Legan, chief surgery consultant to the Air Force Surgeon General.

Statistics from the Pentagon show that the war in Iraq is one of the most survivable in history, with soldiers and Marines surviving injuries that would have killed them in previous conflicts. The percentage of wounded soldiers who have died after reaching a medical facility has risen slightly, however, from 3.5% in Vietnam to 4.1% today.

Army doctors say medics and front-line doctors are more proficient at keeping soldiers with complex injuries alive, thanks to rapid evacuation, increased use of simple tourniquets and airway tubes, and efforts to quickly control bleeding.

Hard evidence that HemCon and QuikClot are saving lives is elusive, however, consisting mostly of anecdotes.

An Army case study published earlier this year summarized 44 uses of HemCon in Iraq and reported that the dressing stopped bleeding in 42 of them. HemCon failed on two because the site of the injuries -- one was a foot wound, the other a head wound -- did not allow for proper adhesion, the study said.

The Marine Corps presented a survey last summer of 68 reported uses of QuikClot and said it stopped bleeding in 65 of them. The three who died all suffered from massive, multiple injuries.

Pentagon officials say official reports or statistics from Iraq indicating the value of hemostatic agents in the field are not available and probably will not be compiled from field reports for several years.

“Obviously, neither one of them is perfect,” said Maj. Gen. Joseph Webb Jr., the Army’s deputy surgeon general, at a congressional hearing in October.

Of HemCon, Webb added: “I think that we’re all anxiously awaiting more data from theater to see how it actually works in combat situations. The limited data that we have back shows that it’s worked very effectively.”