Evaluations of the Combat Ready Clamp to Control Bleeding in Human Cadavers, Manikins, Swine Femoral Artery Hemorrhage Model and Swine Carcasses

Abstract : Hemorrhage remains the major cause of death on the battlefield. While deaths from extremity hemorrhage have been reduced dramatically by the application of tourniquets, deaths from high extremity wounds, such as in the groin region where tourniquets cannot be placed or are less effective, have seen an increase over the course of recent combat operations. In August 20 10, the Combat Ready Clamp (Combat Medical Systems, Fayetteville, NC) received FDA 510(k) clearance for prehospital hemorrhage control of pelvic, groin or buttock bleeding in warfare. Although 500 units have been sold and 125-200 deployed, there is but one anecdotal report of its effectiveness in treating a casualty. This document is a compilation of 4 studies to gather data on the efficacy and initial safety of the Combat Ready Clamp. The studies include initial efficacy testing in a bleeding human cadaver model, an evaluation of efficacy and initial safety in a bleeding human manikin model, live animal testing in a swine groin injury model and evaluation in a swine carcass model of bleeding. The goals of this document are to provide the Combat Developer continued and other decision makers with sufficient data to support continued fielding of the Combat Ready Clamp as the initial fill for a capability gap in theater.