Page 93 - JSOM Winter 2022

While hemostasis was achieved on the first attempt for all CG hemostasis, our data suggest this may be higher with the
treatments, use of the iTClamp resulted in failure to achieve iTClamp than with traditional methods, likely owing to its more
hemostasis on the first attempt in 6 of 25 attempts. We antic- technical nature. Additionally, this failure rate tends to increase
ipated that failed hemostasis and the need for reapplication when it is used in conjunction with packing agents. We feel
would result in slower application times and larger blood this highlights a valuable observation that should be addressed
losses. However, this was not the case due to the ability of the during training on iTClamp use. Specifically, that Operators
iTClamp to be rapidly disengaged and repositioned. Observa- who choose to seal packed wounds with an iTClamp should
tionally, failures in the IT+CG and IT+XS treatment applica- ensure that all gauze is packed tightly into the wound with care
tions appeared to occur secondary to extrusion of the packing to avoid overpacking and that any excess gauze extruding from
material, precluding an effective seal between wound edges. the wound is removed prior to application of the iTClamp.
This was remedied by removing excess packing materials.
Limitations
Previous studies suggested that XSTAT expands more evenly Our study sought to evaluate the immediate utility of me-
and with a balanced pressure distribution compared to gauze chanical wound closure for hemorrhage control, and therefore
packing, increasing hemostasis and decreasing blood loss. 15–17 cannot directly comment on the potential long-term sequelae
Mueller et al. used up to eight syringes of XSTAT to achieve or eventual patient outcomes between techniques. However,
this result, which was not compatible with use of the iTClamp. it seems reasonable that quicker control should result in im-
In our study these attributes did not appear to confer an ad- proved outcomes and decrease resource utilization. Likewise,
ditional advantage over standard of care. Upon necropsy, CG, to reduce confounders, we elected not to administer tranexamic
with or without IT, was more commonly clotted around the acid, provide blood products, or take any other resuscitative
arteriotomy site than IT+XS. measures that may impact the efficacy of hemorrhage control
in trauma patients. Finally, for feasibility purposes we utilized a
While hemostatic efficacy is paramount in the evaluation of he- single, linear wound type and our results may therefore not be
mostatic agents, an agent’s application time can be critical in applicable to all wound types.
the actively hemorrhaging patient. Faster application of hem-
orrhage control devices should result in less blood loss, and Conclusion
once hemorrhage is more quickly controlled, the provider can
address other trauma-associated complications. In prehospital The iTClamp was quicker to apply and as effective in hemo-
settings, faster hemorrhage control also allows for more rapid stasis compared to the standard packing and pressure dressing
6
transport of patients to definitive care. Faster device and agent method. Our findings demonstrate that the iTClamp may be
application can be reasonably anticipated to improve patient effectively used in conjunction with hemostatic packing when
outcomes. Additionally, lengthy application times can be pro- care is taken not to overpack the wound to control junctional
hibitive and even hazardous to both patient and providers in set- hemorrhages of limited complexity and size. Given its efficacy,
tings such as the battlefield, austere locations, or other tenuous speed and compact size, the iTClamp may be well-suited for
environments. As most domestic and foreign terrorism-based fielding with the proper training as an adjunct to standard hem-
incidents continue to involve explosives or firearms, rapid and orrhage control methods, particularly in the prehospital setting.
effective hemorrhage control devices can be a force multiplier
in mass casualty situations by allowing a provider to quickly Acknowledgments
contain hemorrhages from multiple sources or patients. 18 We thank Greg J. Zarow, PhD, for his study design advice.

Our findings supporting the rapid deployment of the iTClamp Disclosure
are consistent with previous reports. 6,9,14 In all three iTClamp The authors have indicated they have no financial relation-
treatment groups, application times were significantly faster ships relevant to this article to disclose.
than traditional packing/wrapping techniques. Furthermore,
investigator time spent with each subject was even longer Funding
during CG application when the additional 3 minutes of direct This research was supported by funding from a Deputy Sur-
pressure that must be held after application per manufactur- geon General Clinical Investigation Award.
er’s recommendations is considered. Additionally, while they
cannot be directly compared across studies, all three iTClamp Author Contributions
treatments were faster than reported applications of current MB contributed to drafting the article or revisiting it critically
junctional tourniquet devices (84–124 seconds). 7 for important intellectual content and final approval of the
version to be published. JM and AW contributed to acquisi-
Unsurprisingly, the application time of the iTClamp alone tion of data. EF contributed to analysis and interpretation of
was faster than when used in conjunction with either CG or data, drafting the article or revisiting it critically for important
XSTAT. The use of CG with the iTClamp required signifi- intellectual content, and final approval of the version to be
cantly more time to apply then with the XSTAT (70 seconds published. SS contributed to all of the above.
and 20 seconds, respectively). These data are consistent with
prior studies which identified XSTAT as a much faster mode References
of wound packing than gauze. 15,17,19 CG comes in a 12-foot roll 1. Eastridge BJ, Hardin M, Cantrell J, et al. Died of wounds on the
that must be manually packed, while XSTAT is applied via a battlefield: causation and implications for improving combat casu-
rapidly deployable single syringe mechanism. alty care. J Trauma. 2011;71(1 Suppl):S4–8.
2. Nti BK, Laniewicz M, Skaggs T, et al. A novel streamlined trauma
response team training improves imaging efficiency for pediat-
There were important observations concerning the use of the ric blunt abdominal trauma patients. J Pediatr Surg. 2019;54(9):
iTClamp. While all agents have a potential to fail to obtain 1854–1860.

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