PORTLAND, Ore – August 10, 2009 – SAM Medical Products today announced the launch of CELOX Trauma Gauze™ at the U.S. Department of Defense’s Advanced Technology Applications for Combat Casualty Care (ATACCC) meeting in Tampa, Fla. CELOX Trauma Gauze is a new dual-purpose hemostatic gauze used to control traumatic bleeding and cool and protect first- and second-degree burns. The product was designed to effectively meet the needs of the armed forces and emergency services personnel who are often working in the field with limited medical supplies. CELOX Trauma Gauze is the newest addition to the CELOX line of temporary traumatic wound treatments.
What is CELOX Trauma Gauze
CELOX Trauma Gauze is composed entirely of CELOX’s chitosan chemistry. Unlike some hemostatic gauze products on the market, CELOX Trauma Gauze is not impregnated or coated with a hemostatic agent. 100% of the chitosan-derived gauze material is used in the treatment of the wound, not just as a delivery system for the hemostatic agent. The new product uses a proprietary manufacturing process to create a soft, compliant and hemostatic gauze that is similar to the look and feel of standard cotton gauze.
The dual-purpose CELOX Trauma Gauze controls traumatic bleeding as well as cools and protects burns. The gauze potentially replaces multiple products — by providing two-in-one functionality, and freeing up valuable space in a battlefield medic’s Improved First Aid Kit (IFAK).
How CELOX Trauma Gauze Works
CELOX Trauma Gauze controls bleeding by reacting with red blood cells to form a robust clot in approximately thirty seconds. As a burn dressing, this product cools and protects first- and second-degree burns through its ability to transform into a gel-like material once saturated with water or a saline solution. One dressing can absorb as much as 430 mL of water or 176 mL of blood and is intuitive, easy to use, and safe for the patient.
CELOX is Safe to Use
CELOX Trauma Gauze has been cleared by the Food and Drug Administration 510(k) for severe bleeding as well as burns. As with other CELOX products, it is not procoagulant and does not contain nanoparticles. CELOX has been in use in emergency and military first aid for the past three years with no reported incidents. An external review was commissioned on the safety of CELOX’s ingredients in the body and concluded that CELOX was safe to use internally in surgery and that residual quantities presented no risk.
“Safety has become a primary concern among the various hemostatic products in the marketplace today,” said Dr. Sam Scheinberg, a U.S. Army surgeon in Vietnam and founder and CEO of SAM Medical Products. “Our new CELOX Trauma Gauze is comprised of chitosan, a natural compound derived from shrimp shells. Chitosan has proven antimicrobial properties and is not procoagulant, unlike some hemostatic products. CELOX’s safety is owed to its ability to be broken down and absorbed through normal metabolic pathways.”
Saving the Lives of our Soldiers & Civilians
According to a recent report from the United States Army Institute of Surgical Research, “On the battlefield, hemorrhage from wounds remains the leading cause of mortality, accounting for 50 percent of all deaths. Hemorrhage is also the second leading cause of mortality among injured civilians, accounting for 39 percent of civilian trauma deaths.”