Page 89 - JSOM Winter 2022

iTClamp-Mediated Wound Closure Speeds
Control of Arterial Hemorrhage With or Without
Additional Hemostatic Agents

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Sean M. Stuart, DO *; Megan L. Bohan, BS ; Julie B. McLean, PhD ;
Alexandra Walchak, MPH ; Emily E. Friedrich, PhD 5
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ABSTRACT
Background: Exsanguination is the leading cause of prevent- can therefore be a lifesaving intervention. However, current
able posttraumatic death, especially in the prehospital arena. treatment options are limited.
Traditional hemorrhage control methods involve packing the
wound with hemostatic agents, providing manual pressure, and The current standard of care involves packing the wound, of-
then applying a pressure dressing to stabilize the treatment. This ten with hemostatic agents, followed by direct, manual pres-
is a lengthy process that frequently destabilizes upon patient sure. However, this method is often ineffective in achieving
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transport. Conversely, the iTClamp, a compact wound closure and maintaining hemostasis during patient movement and
device, is designed to rapidly seal wound edges mechanically, transportation. Importantly, it is a time-consuming approach,
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expediting clot formation at the site of injury. Objectives: To requiring several minutes of manual pressure from a provider,
determine the efficacy of the iTClamp with and without wound time which could be used to both reduce blood loss and allow
packing in the control of a lethal junction hemorrhage. Meth- providers to address other associated trauma complications. 6
ods: Given the limited available information regarding the
efficacy of the iTClamp in conjunction with traditional hemo- One alternative to treating junctional wounds with manual
static agents, this study used a swine model of severe junctional direct pressure is application of a junctional tourniquet. These
hemorrhage. The goal was to compare a multiagent strategy function in the control of junctional hemorrhage by applying
using the iTClamp in conjunction with XSTAT to the tradi- direct pressure over the femoral artery. However, junctional
tional method of Combat Gauze packing with pressure dress- tourniquet application requires the manipulation of the in-
ing application. Readouts include application time, blood loss, jured patient, resulting in variable application times and appli-
and rebleed occurrence. Results: Mean application times of the cation success. Junctional tourniquets have also shown poor
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iTClamp treatment alone or in conjunction with other hemo- stability during simulated patient transport. Finally, junctional
static agents were at least 75% faster than the application time tourniquets are typically bulky devices making them logisti-
of Combat Gauze with pressure dressing. Percent blood loss cally challenging for prehospital care.
was not significantly different between groups but trended the
highest for Combat Gauze treated swine, followed by iTClamp The iTClamp Hemorrhage Control System (iTraumaCare,
plus XSTAT, iTClamp alone and finally iTClamp plus Combat https://www.innovativetraumacare.com/itclamp) is a second
Gauze. Conclusion: The results from this study demonstrate generation wound closure device that has received US Food
that the iTClamp can be effectively utilized in conjunction with and Drug Administration (FDA) approval for the control of
hemostatic packing to control junctional hemorrhages. severe bleeding in the extremities, axilla and inguinal areas.
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This device may address the limitations of standard packing
Keywords: iTClamp; hemorrhage; trauma; junctional wounds; or junctional tourniquet application by mechanically sealing
hemostatic agent the wound and allowing for formation of a stable clot. At
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31.2 g and a size of approximately 6 cm × 4.5 cm × 3.5 cm, the
iTClamp is compact and portable. The simple clamp design
allows for rapid application, and a self-locking mechanism
Introduction
prevents unintentional opening.
Exsanguination is the leading cause of preventable posttrau-
matic death and is responsible for over 35% of deaths in the There are limited studies evaluating the potential benefit of an
prehospital setting alone. While the effective application off-label use of applying iTClamp in conjunction with hemo-
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of tourniquets leads to decreased mortality from extremity static agents. Previously, we developed a swine model to assess
hemorrhage, junctional injuries not amenable to traditional the feasibility of such application in junctional injuries of the
tourniquets continue to pose significant complications in pre- groin, axilla, and neck. Building on that study, we sought to
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hospital medicine. Because junctional areas contain major vas- evaluate the hemostatic efficacy of the iTClamp in conjunc-
cular groups, associated injuries can rapidly lead to death by tion with two hemostatic wound treatments, Combat Gauze
exsanguination. Rapid, in-field control of junctional bleeding (QuikClot, https://quikclot.com/QuikClotProducts/QuikClot
*Correspondence to sean.m.stuart4.mil@health.mil
1 CDR Sean M. Stuart is a physician affiliated with Combat Trauma Research Group, Naval Medicial Center Portsmouth, Portsmouth, VA, and
the Uniformed Services University of the Health Sciences, Bethesda, MD. Dr Julie B. McLean, Dr Emily E. Friedrich, Alexandra Walchak, and
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2 Megan L. Bohan are all affiliated with the Combat Trauma Research Group, Naval Medical Center Portsmouth, General Dynamics Information
Technology (GDIT), Fairfax, VA.
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