Comparison of 4 Hemostatic Agents, CELOX-A, ChitoFlex, WoundStat, and Combat Gauze, Versus Standard Gauze Dressing in Control of Extremity Hemorrhage in a Limited Access Swine Model of Penetrating Combat Trauma

摘要

Objectives.—Exsanguination from extremity wounds remainsnthe leading etiology of preventable combat death. We con-nducted a randomized, prospective, unblinded trial to investigatenthe efficacy of the most commonly used hemostatic agents in anmodel of severe vascular injury with mixed high-pressure ar-nterial and venous bleeding in a small, linear tract wound thatnwas designed to replicate a penetrating injury from a projectilenwhere the bleeding site cannot be directly visualized.nMethods.—A complex groin injury with transection of thenfemoral vessels through a 3-cm entrance wound, followed byn45 seconds of uncontrolled hemorrhage, was created in 80nswine prior to randomization to 5 groups. Group 1 used stan-ndard gauze; group 2 CELOX; group 3 Chitoflex; group 4nCombat Gauze; and group 5 WoundStat. Each agent was ap-nplied with 5 minutes of manual pressure prior to resuscitation.nHemodynamic parameters were recorded over 180 minutes.nPrimary endpoints included initial hemostasis and incidence ofnrebleeding. Secondary endpoints included a composite index ofnadverse events (the 2 primary endpoints and mortality).nResults.—Composite adverse events consisting of mortality,nposttreatment hemorrhage, and failure of initial hemostasisnwere compared between treatment groups using single degreenof freedom u00022nanalysis. Chi-square values were Yates-correctednto obtain conservative tests of statistical significance. Four ofn16 (25%) CELOX-A, 10 of 16 (62.5%) ChitoFlex, 6 of 16n(37.5%) Combat Gauze, 11 of 16 (68.8%) WoundStat, and 7 ofn16 (43.8%) standard dressing subjects suffered from adversenevents. A significant difference was found between the agentsnCELOX-A and WoundStat with respect to composite adversenevents (P u0004 .0335).nConclusions.—Our study demonstrated that CELOX-A wasnsuperior to WoundStat in controlling hemorrhage in smallernlimited access wounds. There were no statistically significantndifferences in gauze products when compared to CELOX-A.nTherefore, standard gauze and adequate wound packing werenfound to perform equally as well as advanced hemostatic agentnproducts in controlling hemorrhage in smaller, linear tractnwounds without direct visualization of the bleeding vessels.