Introduction
Craniomaxillofacial injuries (CMFI) and penetrating neck injuries (PNI) are very common in combat, and can be a challenge to manage with direct manual pressure (DMP). Of course, these regions are not amenable to a tourniquet. Enter the iTClamp™, an innovative and proven device for bleeding management. It can be used independently or in combination with other hemorrhage control techniques, particularly with trauma to the scalp, face, or neck. For these reasons, the Department of Defense, Committee on Tactical Combat Casualty Care (CoTCCC), voted (June 2019) to endorse the iTClamp™ for managing CMFI and PNI in the Tactical Combat Casualty Care (TCCC) Guidelines. Thus, it is our intent to highlight the iTClamp™ as a small, fast, safe and effective tool to manage moderate to severe bleeding in a limited resource environment.
Background
Between 1992-2001 in U.S. emergency departments, nearly 8.2% of cases were seen for an estimated 7 to 9 million lacerations seen annually. The distribution of lacerations were: upper extremity (35%), face (28%), trunk (14.5%), lower extremity (12.5%) and head and neck (10%) for a combined total of 38% to the head and neck. Penetrating neck injury occurs in 5-10% of all civilian trauma cases caused by gunshot wounds (50%) and stab wounds (10-20%), and mortality from PNI ranges between 10-50% depending on mechanism of injury (MOI).
The head, face, and neck comprise approximately 12% of the total body surface area exposed during combat. The risk for CMFI and PNI is greatest to these regions during fragmentation from blast fragments as compared to gunshot wounds. Severe CMFI and PNI trauma can result in substantial hemorrhage and airway compromise requiring emergent intervention. In a ten year period (2001-2011) during the Iraq and Afghanistan conflicts, the U.S. military experienced an incidence of head and neck injuries in 42% of casualties medically evacuated.
The potential for uncontrolled bleeding caused by CMFI and PNI can occur to individuals in the backcountry as a result, for example, falls from height, wild animal attacks, trauma during an avalanche, and mountain bike falls. Frontcountry and backcountry management of CMFI and PNI can be challenging to quickly control bleeding by using DMP in a region with major vessels and highly vascular tissues. Furthermore, it can be cumbersome to apply a bulky dressing in these areas since they can often migrate, resulting in inconsistent DMP. Without early bleeding control of lacerations in the scalp, face, or neck, venous blood loss can result in hypotension, shock and death. Consequently, what medical resources do you carry in your wilderness aid kit to control bleeding from these anatomical regions?
Currently, there are 29 peer reviewed articles about the iTClamp that are either preclinical (animal, cadaver, simulation, human volunteer), clinical (civilian/military, prehospital/hospital), or review articles that have focused on effectiveness, safety, and usability. Notably, three recent publications by Mckee et al. 2018, Mckee et al. 2019 and Onifer et al. 2019 are from two case series, and an evidence-based review article regarding the use of an iTClamp. The most extensive iTClamp case series (N=245) to date is from world-wide (N=15 countries) clinical application as reported by McKee et al. 2018– See Figure 1. These authors used clinical reports from the post market surveillance database as submitted to Innovation Trauma Care, Inc., during April 2013 to October 2016. See Table 1 for the case series demographics for the top five anatomical regions to which the iTClamp was applied, and the top five MOI. These authors conclude that the iTClamp is a fast and reliable method to control external bleeding in 81% of the reported cases. Furthermore, when the iTClamp was applied to the head and neck regions, 87% of N=115 cases achieved bleeding control, independent of wound sizes, shapes and MOI.
Figure 1. Anatomical regions were the iTClamp was applied in McKee et al.