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US Army’s Institute
of Surgical Research
Finds WoundStat™
a Top Hemostatic Agent
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Uncontrolled hemorrhage is the leading cause of death on the battlefield. Even among severe wound survivors, blood loss often leads to further medical complications. Severe blood loss is also life threatening for civilian victims of vehicle accidents, street violence, fires, wilderness accidents and workplace accidents.
A product that can stop arterial bleeding for at least 3 hours would give military and civilian victims alike the time needed to transport them to advanced care facilities.
WoundStat™
Product Description:
WoundStat™ has been scientifically proven to meet the need. It answers every issue. Its per-unit cost is competitive with all hemostatic agents on the market today – but none of them can match its effectiveness.
Because no two wounds are alike, WoundStat™ is granular, allowing it to be poured into, mold and adhere to irregularly shaped and extensive wounds. And, unlike other products, it has shown no evidence of side effects. The mineral based product, produced in the United States, is offered in a moisture-impermeable, sterile, 5.5-ounce foil pouch that can be easily opened by hands or teeth.
PLUS:
WoundStat™- Does NOT burn
- Clots ANTI-COAGULATED human blood
- Works in blood of hemophiliacs
- Works in instances of hemodilution and acidosis
Literature:
WoundStat™ has been tested extensively in animal trauma models followed by the US Army, the US Navy/Marine Corps, and US Air Force. Using these models, considered by some as the “gold Standard” for testing ballistic and other traumatic bleeding, researchers at several institutions found WoundStat™ consistently to out perform other agents in all measures of effectiveness.
A study at Virginia Commonwealth University found that an early version of WoundStat™ enables animal survival in 100 percent of testing cases, while products used by the military failed.1 (www.jtrauma.com)
Another study, conducted by Carraway and colleagues at the North American Research Associates (NAMSA) found identical results: 100 percent of the animals treated with WoundStat™ survived while none of those treated with QuikClot reached hemostasis. In addition, this study demonstrated that there is no exothermic reaction with the use of WoundStat™, unlike the use of QuikClot.2
Most recently, researchers and the US Army Institute of Surgical Research (ISR) published a study that yet again verified the findings of other authors. In this study, WoundStat™ was compared to Celox, SuperQR (not FDA approved), QuikClot ACS+ and the HemCon bandage, the latter being the Army’s fielded choice at the time and served as a control. WoundStat™ outperformed the other agents in terms of wound temperature (none), total amount of blood lost (least), duration of hemostasis (longest), and survival (100 percent.)3
The US Navy presented a study at the 2008 ATACCC meeting (Advanced Tactical Applications for Combat Casualty Care). In this study, WoundStat™ was again a top performer in survival in both a transaction and a puncture femoral artery model.4
Finally, the US Air Force at the Clinical Investigation Facility, David Grant Medical Center, Travis AFB, California conducted another survival study with WoundStat™, this time assessing long term survival at 1, 2, 3, 4, and 5 weeks after vessel repair. In a recently published abstract the researchers concluded: “WoundStat™ was an efficacious procoagulant that promoted survival in a lethal extremity hemorrhage model. Application of WoundStat™ prior to vascular repair of the injury did not appear to negatively affect short-term vascular patency or wound healing.” The Air Force will be examining histologic results in the near future to confirm these findings.5
1Ward, K. et al. 2008. Comparison of a new hemostatic agent to current combat hemostatic agents in a swine model of lethal extremity arterial hemorrhage. J Trauma, 63(2):276-284.
2Carraway, J. et al. 2008. Comparison of a new mineral based hemostatic agent to a commercially available granular zeolite agent for hemostasis in a swine model of lethal extremity arterial hemorrhage. Resuscitation, 78:230-235.
3Navy Medical Research Center. 2008. Comparative Testing of Hemostatic Dressings in a Severe Groin Hemorrhage. Presented at the 2008 annual ATACCC meeting.
4Navy Medical Research Center. 2008. Comparative Testing of Hemostatic Dressings in a Severe Groin Hemorrhage. Presented at the 2008 annual ATACCC meeting.
5Gerlach, T. et al. 2009. A pilot study of the effects of smectite granules (WoundStat™) on vascular repair and wound healing in a survival model of severe groin injury in swine. Presented at the annual meeting of the Society of Air Force Clinical Surgeons, Denver, CO.
Future Products
TraumaCure is working with leading academic experts to develop new products for serious bleeding from multiple etiologies. Our goal is to marry our superior technology with novel delivery systems to address unmet needs in hemostasis. Check our webpage for future announcements.
SAFE USE AND REMOVAL ADVISORY FOR WoundStat™
While there have been no reports of adverse events in humans, recent animal studies of WoundStat™ have suggested that use of the product may be associated with endothelial cell damage and proximal thrombi. As a pre-cautionary measure, the manufacturer recommends the following steps be taken to minimize risks post-treatment in cases where extensive arterial or venous damage has been observed:
- Assure that WoundStat™ is completely removed from the wound once the patient has arrived at a medical treatment facility. High pressure lavage is recommended for removal.
- Repair of the damaged vessel should include removal of damaged tissue, interpositional grafting, and localized use of heparin.
- Monitor the patient to assure blood flow has been established in the repaired vessels and areas proximal and distal. Consider anti-coagulating patient, if appropriate.
- Report any adverse events to the manufacturer.