Page 36 - JSOM Fall 2019

FIGURE 6 Adapted from Eastridge BJ, Mabry RL, Seguin P, et al. for ground combat forces, the preference and recent trend
Death on the battlefield (2001–2011): implications for the future in the US military are for lighter and smaller headgear, with
of combat casualty care. J Trauma Acute Care Surg. 2012;73 more visibility and mobility—in part because of the necessary
(6 suppl 5):S431–S437.
movement required of the neck and because obstructions can
limit senses that are vital in hostile environments. This leads
21
to these regions experiencing disproportionally more fatal
injuries. 36
In September 2018, CoTCCC reviewed the current literature
on the clinical and experimental use of the iTClamp. The fol-
lowing were addressed during this review:

1. What is the mechanism of action of the iTClamp?
2. How does the iTClamp compare with other methods of
hemorrhage control in the head and neck region?
3. What is the evidence for the effectiveness of the device?
4. What are the indications, contraindications, and warnings
for the device?
5. What are the training requirements and knowledge reten-
tion for the use of this device?
6. How safe is the iTClamp to the patient and provider?
and neck region, however, can be difficult to control: tourni- A literature search was conducted to identify clinically rel-
quets are not applicable; CMFI and PNI can be hard to access; evant literature to evaluate the use, safety, and efficacy of
treatment techniques are technically challenging; and dress- the iTClamp. PubMed, Google Scholar, and EMBASE were
ings are difficult to apply and prone to displacement. 21,22,32–34 searched for English-language articles published in the past
Consistent direct pressure is demanding to maintain and has 10 years using the search terms: “direct mechanical pressure,”
been associated with a low success rate due to rebleeding and “iTClamp,” “hemorrhage control clamp,” “acute skin closure
exsanguination prior to reaching definitive care, particularly and hemorrhage,” and “wound seal.” As appropriate, the
in the face of a mass casualty or multiple injuries. 32,35 Rapid searches were repeated with the word “haemorrhage.” The
hemorrhage control for CMFI and PNI remains a challenge Naval Medical Center Portsmouth Combat Trauma Research
on the battlefield with the existing tools. While the head, face, Program provided additional information from currently un-
and neck are only 12% of the body’s surface area exposed published data that were presented at national and interna-
during combat, 15,36 as many as 50% of injured military per- tional conferences.
sonnel will have a CMFI or PNI as one of their wounds. 15,36
Discussion
This prevalence rate is concerning as it is associated with a 10%
to 50% mortality rate due to exsanguination. 28,37,38 Despite the In September 2018, McKee et al. reported 245 cases of
prevalence of CMFI and PNI reported, and their association iTClamp use for hemorrhage control in the Journal of Spe-
with uncontrolled hemorrhage, there is still a tendency to ig- cial Operations Medicine (Figures 7 and 8). These cases were
8
nore or minimize these injuries. This highlights the notion self-reported by users as part of the manufacturer’s postmar-
28
that care providers continue to underestimate blood loss from keting surveillance effort during the period April 2013 to
the scalp, which, left untreated, can lead to anemia, shock, and October 2016.* Of the 245 cases of iTClamp use, 81% (n =
even death. 22,28 198) were reported to result in adequate hemorrhage control.
Analysis of use by anatomical location showed 115 applica-
During a mass casualty event or when managing a polytrauma tions to the head and neck with 87.0% reporting adequate
patient, a decrease in the quality of trauma care can be ex- hemorrhage control. The iTClamp demonstrated effective
perienced, and missed injuries are common. As many as hemorrhage control across all anatomical regions, a variety of
40
39
8% of polytrauma patients are found to have missed clinically wound sizes and shapes, and multiple mechanisms of injury.
significant injuries, 37% of which are head and neck injuries.
40
Polytrauma patients are up to 2.61 times more likely to have The iTClamp is small and lightweight (approximately 1 oz)
missed head and neck injuries. In this situation, discounting with FDA-approved indications for use on multiple sites. It
CMFI or PNI hemorrhage can be particularly prominent and works in all compressible areas, including large and irregular
dangerous. 40 lacerations, and on the scalp.
Prevention of these injuries would be preferable, but de- Numerous case reports 4–7,41–43 and animal 44–46 and cadaver 47,48
spite many depictions of full-facemask, pilot-type helmets studies demonstrate iTClamp effectiveness and ease of use for

*“Medical device manufacturers as well as other firms involved in the distribution of devices must follow certain requirements and regulations
once devices are on the market. These include such things as tracking systems, reporting of device malfunctions, serious injuries or deaths, and
registering the establishments where devices are produced or distributed. Postmarket requirements also include postmarket surveillance studies
required under section 522 of the [Federal Food, Drug, and Cosmetic] Act as well as post-approval studies required at the time of approval of
a premarket approval, humanitarian device exemption, or product development protocol application.” (https://www.fda.gov/MedicalDevices
/DeviceRegulationandGuidance/PostmarketRequirements/default.htm)

34 | JSOM Volume 19, Edition 3 / Fall 2019