Page 41 - JSOM Fall 2019

3. The device will not control hemorrhage in noncompressible simulated blood flow was 14 seconds for physicians and 15
sites, such as the abdominal and chest cavities; seconds for first aid workers. Comparable rapid, effective
4. When used to control hemorrhage in the neck, consider the performance was achieved in both groups with ultra-short,
need for appropriate airway management as per local pro- video-only training. This not only demonstrates the easy ac-
tocols under medical direction; and quisition of the necessary skills for effective use of the device
5. The device is not compatible with magnetic resonance im- but also suggests that that purely digital learning without
aging (MRI) procedures. hands-on training may be an effective training method.

Although there have been no case reports of airway compro- Retention of training in nonmedical personnel was described
mise in neck injuries treated with the iTClamp, when using the in a 2016 report with favorable results. Tactical police offi-
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device to treat a PNI, the airway should always be frequently cers were trained in the use of the iTClamp. Their training was
monitored to ensure that hematoma formation does not cause tested by the completion of a written examination, and then
airway compromise. This is not an additional requirement for the monitored proper application of the iTClamp to a bleeding
the person providing care since airway monitoring should be simulator; 100% of the participants passed both the written
the standard of care in the management of any neck injury; test and the skills assessment—no one needed to be stopped
however, there should be a reinforcement of the need for air- due to improper or unsafe application. Four months later, the
way monitoring when the iTClamp is used. same group of officers was retested. They had no exposure
to the iTClamp in the intervening time. Of the 15 officers,
The iTClamp is designed to provide temporary control of 14 were able to safely and correctly apply the device to the
hemorrhage in wounds that will eventually require definitive bleeding simulator. One officer was unable to complete the
surgical care. iTClamp placement and effectiveness should be task and was stopped for unsafe handling of the device. This
monitored during treatment and transport to ensure that he- study demonstrates that nonmedical personnel can be trained
mostasis is maintained and the device is secure. The device to use the iTClamp effectively and that they maintain excellent
has FDA approval for up to 24 hours of application time. Al- knowledge retention.
though there have been no reports of harm from prolonged
placement of the device, its use has not been studied past 6 The results of these training studies should also be compared
hours. to the current standard treatment modalities for external hem-
orrhage. Wound packing with a hemostatic dressing, for ex-
5. What are the training requirements and knowledge reten- ample, may seem like a straightforward process but evidence
tion for the use of the iTClamp? suggests otherwise. A study was done with 33 experienced Is-
A 2014 article from the International Review of the Armed raeli Defense Force (IDF) medics using Combat Gauze and a
Forces Medical Services looked at what level of medical wound packing simulator. The model was validated by a phy-
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background was required and how intuitive was it to operate sician instructor to verify that it was not too difficult for medic
the device without prior instruction. The data showed no dif- use. Half the medics were randomized to being mentored and
ferences based on medical background and the device could be half were not. Only 5/33 (15%) medics were able to adequately
used by first aid responders, police officers, EMTs, and physi- pack the wound and pass, four of whom were mentored. Of
cians (15 volunteers in total) with equal proficiency and with the 85% of medics that did not pass, 70% of them thought that
no prior training. Average time to the first application without they had passed and most thought that the scenario was not
training was 13.1 seconds. A second application was repeated difficult (ranked 4.5/10). This illustrates that wound packing
with wet gloves and averaged 6.8 seconds. may not be as effective as expected in first responders and that
there may be a significant training requirement to maintain
A study evaluating the ability of tactical police to control proper skill for application of hemostatic dressings.
hemorrhage with the iTClamp was published in the Canadian
Journal of Surgery in 2015. Using a model of massive up- 6. How safe is the iTClamp to the patient and provider?
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per extremity arterial hemorrhage, study participants applied Considering that the mechanism of action of the iTClamp re-
the iTClamp with both dry and wet gloves to simulate ap- quires four pairs of needles to penetrate the patient’s skin and
plication in the presence and absence of blood. The primary compress the wound edges in order to achieve a seal, it is nec-
outcomes were the ability to achieve hemostasis and time to essary to evaluate the safety of the device and its potential for
achieving hemostasis during both wet and dry applications. causing pain.
All participants were able to achieve hemostasis in both dry
and wet applications. There was no significant difference in Investigators used a cadaver model to look at the depth of
time to application between dry and wet applications (median, needle penetration and conducted CT angiograms to look at
5.5 versus 6.2 sec; p = .654). During 46 applications and re- the nature of the simulated hematoma formation and how it
movals, there were no needle stick injuries sustained from the affected distal arterial flow. The needles penetrated an av-
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eight needles contained in the iTClamp device. All participants erage 4.2mm into the skin with a 10mm maximum depth of
rated the iTClamp easy to use and were confident in their abil- penetration. The CT angiograms found the hematomas to be
ity to apply the device. contained in the muscle and subcutaneous tissues and distal
flow was preserved in a partially injured artery.
The 2015 CLICK-CLACK study from France evaluated the
level of difficulty entailed in training personnel to use the Our review has found no reports or evidence of tissue injury
iTClamp. Thirty-three emergency physicians and 35 first- from iTClamp application. In an animal study, investigators
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aid workers were shown a 47-second video on applying the applied the iTClamp for 180 minutes to surgically created
iTClamp and then asked to apply the clamp on a validated wounds. Skin tissue samples were harvested at necropsy for
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arterial bleeding arm simulator. The median time to stop histologic examination. Histopathology found no observable
iTClamp Mechanical Wound Closure Device | 39