US Army’s Institute
of Surgical Research
Finds WoundStat™
Top Hemostatic Agent

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Study Abstract

FAQs

What is WoundStat?
WoundStat is a granular mineral blend that stops bleeding in seconds when applied directly to external wounds. WoundStat is the only product that had 100% survival of all animals in tests performed by the US Army Institute of Surgical Research. In multiple studies conducted by the US Army, Navy and Air Force, WoundStat was the most effective hemostatic agent tested overall.
Is WoundStat FDA approved?
Yes. After in depth review of in vitro and in vivo data, the FDA found WoundStat both effective in stopping moderate to severe bleeding and completely safe to use.
Is WoundStat cleared by the FDA for over-the-counter purchase?
Yes. WoundStat has over-the-counter clearance from the FDA. Like other hemostatic agents, WoundStat was originally only a prescription product when it was first introduced.
How does WoundStat compare in effectiveness to other hemostatic dressings?
WoundStat is the only US Army-tested product that had 100% survival of all animals. Five different studies have shown WoundStat is the most effective hemostat available for high pressure arterial wounds. WoundStat consistently resulted in the least amount of blood loss, longest hemostasis times among tested products, and stabilized the wound for several hours. WoundStat works in seconds, not minutes, which makes a significant difference when operating in high threat, high stress environments.
When should WoundStat be used?
WoundStat is indicated for use in situations with moderate to severe bleeding. WoundStat is particularly helpful in stopping even high pressure arterial bleeding, which remains a major problem for medics and warfighters. Most products will be flushed out by the high-pressure bleed. WoundStat will not.

In particular, WoundStat was designed to treat the complex and irregular wounds that are unique to blast injuries. The military estimates that 90 percent of the injuries on the battlefield today are from blasts and not gun shot wounds.

According to Col. Lorne Blackbourne, commander of the US Army Institute of Surgical Research, “With WoundStat, the real target is the wound that cannot take a tourniquet”…but can take compression, including the groin, neck, underarm, and subclavia. “That represents up to 20 percent of the potentially salvageable wounds we’re seeing on the battlefield.”
Is WoundStat safe?
WoundStat has been cleared by the FDA and found both safe and effective. The product has been used in both Iraq and Afghanistan with no reports of side effects. With its recent introduction into the domestic EMS community, WoundStat has been used at least three times in the US – once for a gun shot wound victim, the other two times for the victims of motor vehicle accidents. Each of those incidents resulted in full recovery with no reported adverse events for the patients. Finally, there have been no reports to the FDA of any adverse effects of using WoundStat.

The core material in WoundStat has been on the FDA’s Generally Regarded as Safe (GRAS) list for years. The material has been used for a number of other medical applications without any reports of problems.
Does WoundStat have an exothermic reaction?
There is NO exothermic reaction with the use of WoundStat. This fact has been verified in multiple studies, including those completed by the US Army, Navy/Marines, Air Force, and Virginia Commonwealth University.
Does WoundStat enter the lumen of the arteries or veins?
There is no evidence or reported experience that WoundStat or any other hemostatic granule or powder is left in the vascular system after field application and standard debridement. Other granular products (some of which are equally as procoagulant as WoundStat) have been used in the field for over 5 years and there are no such reports related to their use, nor have there been any adverse result reports filed as required by FDA regulations.

However, even if there were a theoretical risk of this or any other product causing a clot, “As surgeons, we’d much rather have a live patient come to us with a clot in the vessel, which we can fix almost all the time. One thing we don’t want to lose sight of is this will save the warfighter’s life and get them to a surgeon” said Col. Lorne Blackbourne, commander of the US Army Institute of Surgical Research.
How does WoundStat work?
WoundStat works by, first, absorbing the blood into the granules of the product. Second, immediate simultaneous packing of WoundStat into the wound forms a sticky seal or cast over the bleeding vessels. This property makes WoundStat the ONLY product capable of turning a non-compressible wound almost instantly into a compressible wound. The cast made by WoundStat allows topical pressure applied to the wound to be transmitted with high fidelity across the entire wound surface, thus enhancing the value of pressure in achieving and maintaining hemostasis.

Finally, the negative charge of the material accelerates the natural clotting process at the bleeding sites, further enhancing the ability to rapidly obtain long lasting hemostasis.

The combination of these effects allows WoundStat to be poured through a pool of blood and does not require removing the blood to identify the source of bleeding. Also, should rebleeding occur during movement, WoundStat can simply be remolded into the wound to achieve hemostasis. This is not possible with gauze products. Once WoundStat is molded into the wound, it forms an impervious barrier and is not affected by environmental conditions such as rain.
Is WoundStat difficult to remove from the wound?
No. WoundStat is not difficult to remove, if the instructions for irrigation and debriding are followed. We recommend normal levels of wound irrigation that are typically used in theatre and in emergency departments and trauma operating rooms currently in the US for treatment of contaminated wounds.
Can debridement be avoided if a gauze product rather than WoundStat granules were used for staunching bleeding?
No. Ballistic injuries in the field, especially from IEDs, require removal of debris such as dirt, sand, and shrapnel, so irrigation and debridement is a routine occurrence. Using WoundStat granules does not require a separate step in this process. Normal levels of irrigation will remove WoundStat granules from the wound cavity.

In addition, procoagulant particles imbedded in recently introduced gauze products will discharge into the wound cavity when in contact with aqueous solutions such as blood. Two tests conducted by independent industrial laboratories demonstrated that the field gauze containing pro-coagulant nanoparticles of an inert substance released up to 5 grams of the active ingredient per roll. This material would need to be debrided as well, with the added complication that the particles are almost microscopic and difficult to see with the naked eye, thus increasing the risk of the material being left in the wound.
What has been the experience in debriding wounds in people?
The experience of DJ Green, MD, Assistant Professor of Surgery in the Division of Trauma & Surgical Critical Care in the Naval Trauma Training Center at USC Medical Center, is illustrative. He used WoundStat in a victim of a motor vehicle accident. Dr. Green has stated: "I used WoundStat in a patient after a motor vehicle accident. The surgery was extremely long and very bloody. The WoundStat maintained hemostasis and washed out easily. I will try the product again."

Rao R. Ivatury, MD, Chief of the Division of Trauma Surgery at the Virginia Commonwealth University Medical Center also reported on use of WoundStat for a patient with a gun shot wound to the groin. According to Dr. Ivatury, “Once WoundStat was poured into the wound, the bleeding stopped. We were then able to prep and drape the whole area for the surgical repair of the artery. WoundStat provided easier control of bleeding and an easier approach to the exposure of the vessels. It also provided time for the resuscitation and allowed a deliberate active exposure and repair of the vessel.” About removal, Dr. Ivatury said WoundStat was easily debrided.

Both of these patients recovered and there were no reported complications with the use of WoundStat.
Is WoundStat a procoagulant?
In vitro testing by TraumaCure and the US Army shows that WoundStat is pro-coagulant. Additionally, WoundStat forms a tight seal across the complex surface of a ballistic injury, staunching even high-pressure bleeding from multiple sites. This is why the product works so well. Other mineral-based products are procoagulant as well, but WoundStat stops bleeding in SECONDS NOT MINUTES, which is critical, especially when time counts in battle.
Is it difficult to learn how to apply WoundStat?
No, it is not difficult. Our training video is the answer to how easy it is to train for the use of WoundStat. The major steps are POUR, PACK with pressure, and place a pressure DRESSING. Customer feedback and experience with using this video indicate that the training tool is well received and quite effective. Please see our website (www.traumacure.com) to view the training, application and debridement videos.
Is it better to use gauze rather than granules for ballistic injuries?
It depends. Because predicting the geometry of wounds and location of the bleeding vessel is impossible, the TCCC recommended that troops carry both WoundStat as well as a gauze product. As noted by the medics on the TCCC, gauze can be useful for small entry wounds. However, today in Iraq and Afghanistan, 90% of the injuries result from blasts, not bullets. Blast injuries can be large, gaping, irregular, and bleed profusely. Even small blast injuries can be quite complex and ill-suited to a fixed bandage-type treatment. These types of injuries call for a product that can be poured through blood (no need to remove the pool of blood first), can find its way deep into the wound (easier for particles than gauze), stops bleeding at its source, and stays in place for the period of time necessary to be transported to an operating room. WoundStat has all of these attributes. This is the main reason the medics on the TCCC wanted both products.
Does the wound need to be cleaned to apply WoundStat?
No. That is the beauty of the product. WoundStat can be poured through a pool of blood and it will still work within seconds. And unlike other products, you do not need to identify the bleeding site for the product to work. Further, if WoundStat does not stop the bleeding quickly or should bleeding reoccur, you need not remove it. Just remold the existing product to conform to the wound or apply additional WoundStat. The super absorbent granules in WoundStat will continue to work.

How does WoundStat compare to other hemostatic agents?

	WoundStat	Combat Gauze	Celox
Conforms to Irregular Wounds
Stops Bleeding in Seconds
No Need to Visualize Bleeding Site
Can be Remolded
Easy to Debride
Least Blood Loss
Makes a Wound Compressible
Most Consistent Survival Rates
Maintains Hemostasis Longest