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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.

Onifer et al. presented evidence-based rationale for managing CMFI and PNI on the battlefield with the iTClamp, based on the mechanism of action, indications, contraindications, warnings, effectiveness, safety, and training requirements – See Table 2. They concluded that the iTClamp™ is a low cost, lightweight, small profile, durably designed, and an effective mechanical device for bleeding control in the head, and without airway and vascular compromise in the neck when compared to DMP. Furthermore, they stated this device can be safely and effectively used by all individuals with varying experience levels. Based on the level of evidence presented by Onifer et al., the CoTCCC members ultimately approved this device for inclusion in the TCCC Guidelines – (See Table 3).

Source: Innovative Trauma Care Inc.

iTClamp Application 

The iTClamp™is FDA approved (May 2013) as a prescription-only, disposable device for temporary control of severe bleeding in the extremity, axillary, inguinal, scalp and neck wounds. This device quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma – see Table 4 for iTClamp device specifications. The iTClamp is a self-locking clamp with eight needles. These needles penetrate, and evert the skin edges, and the pressure bars evenly distribute pressure to reduce slippage and leakage. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid-tight seal through wound edge approximation. This action stops the bleeding until definitive management and possible surgical repair.

Source: Current TCCC Guidelines

To apply the iTClamp™, open the sterile package by pulling forward on the outer tabs. Remove the device from the package by lifting up, taking care to not close the device until it has been applied to the wound. Locate the wound edges and align the device parallel to the length of wound edge. See Figures 2a & 2b for a step by step application of the iTClamp™.

Figure 2a. iTClamp™ step-by-step application.

Figure 2b. iTClamp™ step-by-step application. 

Mechanism of Action

The iTClamp™ uses the hydrostatic backpressure of a hematoma inside a wound cavity to generate pressure and produce a hemostatic effect on the injured vessel. This seal creates a hematoma that tamponades injured vessels via hydrostatic pressure to replace direct pressure on the injured vessel – see Figure 3. Once the hydrostatic pressure in the wound cavity equalizes with the internal pressure of the injured vessel, it creates a hemostatic environment independent of coagulation factors. This video describes this mechanisms of action.
     
Figure 3. CT angiogram of a 6 mm arteriotomy made to the common carotid artery of a reperfused cadaver. The clamp is in place at the skin creating a pressurized hematoma which equalizes with the pressure of the injured vessel and creates a zone of stasis.

Source: Mottet K et al

There are many online resources for iTClamp™ training and reference training. See Table 5 for a series of iTClamp™ training videos, and Table 6 for iTClamp™ application tips and tricks. Check out the iTClamp™ bibliography of peer reviewed studies.

iTClamp™ Initial Training and Refresher Training Resources

All video resources for training were produced by the company that developed the iTClamp™ – Innovative Trauma Care Inc, San Antonio, TX. All videos below were granted permission by Innovative Trauma Care Inc. https://www.innovativetraumacare.com/
 

Table 5. iTClamp™ video training resources

Feature comparison between the original iTClamp™ and the new, improved V2 version. The iTClamp™ is an FDA cleared temporary bleeding control device that can be used in the scalp, neck, extremities, groin and axilla areas. The device seals the edges of a wound closed to create a stable clot to mitigate further blood loss until the wound can be surgically repaired.  
youtube.com/watch?v=ZQBnUWqIUMQ 

The iTClamp™ Hemorrhage Control System is a temporary wound closure device to control severe bleeding within seconds of application to a traumatic injury. The iTClamp™ seals the edges of a wound closed to create a temporary pool of blood under pressure, which forms a stable clot that mitigates further blood loss until the wound can be surgically repaired.
youtube.com/watch?v=iVO-QRTGM7U 

Comparison of the typical hemorrhage control procedures versus hemorrhage control procedures incorporating the iTClamp™.
youtube.com/watch?v=aethhAraJeU  

Multiple iTClamp™ can be used on large wounds to control hemorrhage.
youtube.com/watch?v=8b8E2JQTMhc  

The CEO/Medical Director/Inventor, Innovative Trauma Care Inc., demonstrates the ITClamp™, a clamp that is intended for use by emergency responders to instantly close life threatening open wounds on the body. Video by Larry Wong.
youtube.com/watch?v=CTKxQfDu4jA  

iTClamp™ application to a laceration on the scalp.
youtube.com/watch?v=H9BzhromF5E 

Customers at the Innovative Trauma Care booth self-apply to confirm the claim that pain levels are 2-3 on the pain scale (max of 10).
youtube.com/watch?v=cH32ODgiWP0&feature=emb_logo 

WMS Online lecture (CME) overview of the iTClamp™ that was presented at the WMS Summer Conference, Breckenridge, CO, July 2017. Login at www.wms.org.

Table 6. iTClamp™ Application Tips and Tricks

1. Rule of Thumb: wounds longer than your thumb (5 cm) need multiple iTClamps™ and each device can be positioned to close non-linear wounds.

2. Obvious Feedback: when device not placed correctly blood leaks from the wound edges.

3. Can be repositioned if needed.

4. Can be used with other bleeding control techniques (pack a large wound cavity with hemostatic gauze before closing the wound edges with the iTClamp™).

5. Can be used for tourniquet conversion with a combination of hemostatic gauze and an iTClamp™.

6. Can be used for temporary wound closure from soft tissue lacerations.

7. Can be used for securing a chest tube midaxillary after positioning in the thoracic cavity.

8. Can partially close the device before scalp application (skin is under more tension).

Final Thoughts

The iTClamp™ is an adjunct device to consider adding to your armamentarium for managing bleeding. It is a well published device with worldwide use in both civilian and military applications for a laceration or penetration in the challenging regions of the head, face and neck. Furthermore, this device has been applied in other anatomical regions with proven effectiveness and safety. Learning to use the iTClamp™ is easy, fast and it is intuitive as a lightweight, small cube, multi-use device that causes only minimal pain. Consequently, this makes it an ideal hemorrhage control device, and is capable of other improvised uses by first responders, park rangers, wilderness EMS personnel, mid-level providers and physicians for backcountry trauma.  

Note: All photos and videos were granted permission by Innovative Trauma Care Inc.

The authors have no conflict of interests with the iTClamp™ device or any aspect with Innovative Trauma Care Inc.

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