NuStat 4x4 Hemostatic Dressing

Background: Uncontrolled hemorrhage remains one of the most challenging problems facing emergency medical professionals and a leading cause of traumatic death in both battlefield and civilian environments. Survival is determined by the ability to rapidly control hemorrhage. Several commercially available topical adjunct agents have been shown to be effective in controlling hemorrhage, and one, Combat Gauze (CG), is used regularly on the battlefield and for civilian applications. However, recent literature reviews have concluded that no ideal topical agent exists for all injuries and scenarios. The authors compared a novel nonimpregnated dressing composed of cellulose and silica, NuStat (NS), to CG in a lethal hemorrhagic groin injury. These dressings were selected for their commercial availability and design intended for control of massive hemorrhage.

Methods: A complex penetrating femoral artery groin injury was made using a 5.5mm vascular punch followed by 45 seconds of uncontrolled hemorrhage in 15 swine. The hemostatic dressings were randomized using a random sequence generator and then assigned to the animals. Three minutes of manual pressure was applied with each agent after the free bleed. Hextend bolus (500 mL) was subsequently rapidly infused using a standard pressure bag along with the addition of maintenance fluids to maintain blood pressure. Hemodynamic parameters were recorded every 10 minutes and additionally at critical time points defined in the protocol. Primary end points included immediate hemostasis upon release of manual pressure (T0), hemostasis at 60 minutes, and rebleeding during the 60-minute observation period.

Results: NS was statistically superior to CG in a 5.5 mm traumatic hemorrhage model at T0 for immediate hemostasis (p=.0475), duration of application time (p=.0093), use of resuscitative fluids (p=.0042) and additional blood loss after application (p=.0385). NS and CG were statistically equivalent for hemostasis at 60 minutes, rebleeding during the study, and the additional secondary metrics, although the trend indicated that in a larger sample size, NS could prove statistical superiority in selected categories.

Conclusions: In this porcine model of uncontrolled hemorrhage, NS improved immediate hemorrhage control, stability, and use of fluid in a 60-minute severe porcine hemorrhage model. In this study, NS demonstrated equivalence to CG at achieving long-term hemostasis and the prevention of rebleed after application. NS was shown to be an efficacious choice for hemorrhage control in combat and civilian emergency medical service environments.