Abstract
Objectives
Exsanguination from extremity wounds remains the leading etiology of preventable combat death. We conducted a randomized, prospective, unblinded trial to investigate the efficacy of the most commonly used hemostatic agents in a model of severe vascular injury with mixed high-pressure arterial and venous bleeding in a small, linear tract wound that was designed to replicate a penetrating injury from a projectile where the bleeding site cannot be directly visualized.
Methods
A complex groin injury with transection of the femoral vessels through a 3-cm entrance wound, followed by 45 seconds of uncontrolled hemorrhage, was created in 80 swine prior to randomization to 5 groups. Group 1 used standard gauze; group 2 CELOX; group 3 Chitoflex; group 4 Combat Gauze; and group 5 WoundStat. Each agent was applied with 5 minutes of manual pressure prior to resuscitation. Hemodynamic parameters were recorded over 180 minutes. Primary endpoints included initial hemostasis and incidence of rebleeding. Secondary endpoints included a composite index of adverse events (the 2 primary endpoints and mortality).
Results
Composite adverse events consisting of mortality, posttreatment hemorrhage, and failure of initial hemostasis were compared between treatment groups using single degree of freedom γ2 analysis. Chi-square values were Yates-corrected to obtain conservative tests of statistical significance. Four of 16 (25%) CELOX-A, 10 of 16 (62.5%) ChitoFlex, 6 of 16 (37.5%) Combat Gauze, 11 of 16 (68.8%) WoundStat, and 7 of 16 (43.8%) standard dressing subjects suffered from adverse events. A significant difference was found between the agents CELOX-A and WoundStat with respect to composite adverse events (P = .0335).
Conclusions
Our study demonstrated that CELOX-A was superior to WoundStat in controlling hemorrhage in smaller limited access wounds. There were no statistically significant differences in gauze products when compared to CELOX-A. Therefore, standard gauze and adequate wound packing were found to perform equally as well as advanced hemostatic agent products in controlling hemorrhage in smaller, linear tract wounds without direct visualization of the bleeding vessels.