Page 41 - JSOM Fall 2018

Worldwide Case Reports
Using the iTClamp for External Hemorrhage Control

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Jessica L. Mckee, BA, MSc *; Andrew W. Kirkpatrick, MD, FRCSC ;
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Brad L. Bennett, PhD ; Don Jenkins, MD ; Sarvesh Logsetty, MD ;John B. Holcomb, MD 6
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ABSTRACT
Background: Historically, hemorrhage control strategies con­ also a major challenge and carry a mortality rate of 10% to
sisted of manual pressure, pressure dressings, gauze with or 50% with bleeding from major vascular injuries accounting
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without hemostatic ingredients for wound packing, or the use for 50% of the deaths. 10
of tourniquets. The iTClamp is a relatively new alternative to
stop external bleeding. Methods: An anonymous survey was Effective hemorrhage control methods for scalp and neck
used to evaluate the outcomes of the iTClamp in worldwide wounds are limited. Research has also demonstrated a posi­
cases of external bleeding. Results: A total of 245 evaluable tive correlation between prehospital response time and mor­
applications were reported. The iTClamp stopped the bleeding tality, particularly with penetrating injury, specifically gunshot
in 81% (n = 198) of the cases. Inadequate bleeding control wounds and stabbings. Therefore, with the number of poten­
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was documented in 8% (n = 20) and in the remaining 11% tial wounds that will need treatment and the qualifier that in
(n = 27), bleeding control was not reported. The top three an­ cases of hemorrhage the “scoop and run” mentality may save
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atomic body regions for iTClamp application were the scalp, lives, a device that can save time and is hands­free but still
37% (n = 91); arm, 20% (n = 49); and leg, 19% (n = 46). In safe and effective, even with less demanding wounds, can al­
26% of the reported cases (direct pressure [23% (n = 63)] and leviate the gap in prehospital hemorrhage control and wound
tourniquets [3% (n = 8]), other techniques were abandoned care, particularly in anatomic regions where a tourniquet can­
in favor of the iTClamp. Conversely, the iTClamp was aban­ not be applied.
doned in favor of direct pressure 11 times (4.4%) and aban­
doned in favor of a tourniquet three times (1%). Conclusion: Postmarket surveillance is a tool used to ensure the safety of
The iTClamp appears to be a fast and reliable device to stop pharmaceutical drugs and medical devices after they have been
external bleeding. Because of its function and possible applica­ released to the market. There are several modalities for post­
tions, it has potential to lessen the gap between and add to the market surveillance, including, but not limited to, spontaneous
present selection of devices for treatment of external bleeding. reporting databases. Postmarket surveillance is required at the
company level by the European Medicines Agency (EMA) and
Keywords: trauma; bleeding control; emergency medical can be required by the Food and Drug Administration (FDA) for
service; iTClamp certain class II and class III medical devices. Health Canada (HC)
does not require formal postmarket surveillance at the company
level; however, all reportable incidents must be reported to HC.
Introduction Data collected at the company level for postmarket surveillance
are collected very stringently. This information helps inform the
It is well understood that bleeding is the leading cause of pre­ risk­benefit management of each product and can lead to prod­
ventable death in traumatic injuries of all types ; however, fur­ uct warnings, labelling changes, and even product recalls. Com­
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ther examination of this issue reveals that the epidemiology of panies face severe governmental agency (i.e., EMA, FDA, and
wounds in general, not just life­endangering wounds, is signif­ HC) castigation for not reporting adverse events.
icant. In 2005, nearly 12 million wounds were treated in the
hospital emergency departments, of which 7.3 million were One such medical device approved by HC, FDA, and EMA is
lacerations. An additional 2 million people were treated as the iTClamp (Innovative Trauma Care [iTraumaCare], https://
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outpatients for a cutting or piercing incident, nearly 5 million www.innovativetraumacare.com). The iTClamp quickly con­
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animal bites were treated, and 1.5 million skin tears in the trols critical bleeding by closing the skin to create a temporary,
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elderly occur annually. Brookes et al reported that nearly half contained hematoma until surgical repair. The iTClamp is a
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of all civilian trauma incidents include a scalp laceration, an self­locking trauma clamp with eight needles. These needles
anatomic region where hemorrhage is a challenge to control penetrate the skin to evert the skin edges between pressure
and where missed or uncontrolled injury can result in hypo­ bars of the device and anchor the device to the skin to reduce
tension, shock, and even death. Penetrating neck injuries are slippage and leakage. Pressure is evenly distributed across
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*Correspondence to Jessica.Mckee@ualberta.ca
1 Ms Mckee and Dr Kirkpatrick are at University of Calgary, Calgary, Alberta, Canada; Dr Kirkpatrick is at Regional Trauma Services, University
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of Calgary; Dr Bennett is at Military & Emergency Medicine Dept, F. Edward Hébert School of Medicine, Uniformed Services University of the
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Health Sciences, Bethesda Maryland; Dr Jenkins is at Department of Surgery, Division of Trauma and Emergency General Surgery, University
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of Texas Health Science Center, San Antonio, Texas; Dr Logsetty is at Department of Surgery, Max Rady College of Medicine, Rady Faculty of
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Health Sciences, Winnipeg, Manitoba, Canada; Dr Holcomb is at Department of Surgery, Division of Acute Care Surgery at The University of
Texas Health Science Center.
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