Management of Hemorrhage From Craniomaxillofacial Injuries and Penetrating Neck Injury in Tactical Combat Casualty Care: iTClamp Mechanical Wound Closure Device TCCC Guidelines Proposed Change 19-04 06 June 2019

The 2012 study Death on the battlefield (2001-2011) by Eastridge et al.1 demonstrated that 7.5% of the prehospital deaths caused by potentially survivable injuries were due to external hemorrhage from the cervical region. The increasing use of Tactical Combat-Casualty Care (TCCC) and other medical interventions have dramatically reduced the overall rate of combat-related mortality in US forces; however, uncontrolled hemorrhage remains the number one cause of potentially survivable combat trauma. Additionally, the use of personal protective equipment and adaptations in the weapons used against US forces has caused changes in the wound distribution patterns seen in combat trauma. There has been a significant proportional increase in head and neck wounds, which may result in difficult to control hemorrhage. More than 50% of combat wounded personnel will receive a head or neck wound. The iTClamp (Innovative Trauma Care Inc., Edmonton, Alberta, Canada) is the first and only hemorrhage control device that uses the hydrostatic pressure of a hematoma to tamponade bleeding from an injured vessel within a wound. The iTClamp is US Food and Drug Administration (FDA) approved for use on multiple sites and works in all compressible areas, including on large and irregular lacerations. The iTClamp's unique design makes it ideal for controlling external hemorrhage in the head and neck region. The iTClamp has been demonstrated effective in over 245 field applications. The device is small and lightweight, easy to apply, can be used by any level of first responder with minimal training, and facilitates excellent skills retention. The iTClamp reapproximates wound edges with four pairs of opposing needles. This mechanism of action has demonstrated safe application for both the patient and the provider, causes minimal pain, and does not result in tissue necrosis, even if the device is left in place for extended periods. The Committee on TCCC recommends the use of the iTClamp as a primary treatment modality, along with a CoTCCC-recommended hemostatic dressing and direct manual pressure (DMP), for hemorrhage control in craniomaxillofacial injuries and penetrating neck injuries with external hemorrhage.