The iTClamp Controls Junctional Bleeding in a Lethal Swine Exsanguination Model

Abstract

Objective.Severe hemorrhage is a leading cause of death and difficult to control even by trained medical personnel. Current interventions have significant limitations in the prehospital setting; therefore, a need exists for a new and effective treatment. iTraumaCare has designed a temporary wound closure device, the iTClamp, which controls external hemorrhage from open wounds within compressible zones. The device approximates the wound edges, sealing the skin within a pressure bar, enabling creation of a hematoma and subsequent clot formation. The objective of this study is to test the effectiveness of the iTClamp to control external bleeding due to a major vascular injury to the groin in an in vivo swine model.Methods.Twenty Yorkshire-cross male swine were enrolled in this study. A complex groin injury was created by complete excision of the femoral artery and vein along with some surrounding muscle. The animals were divided into four treatment groups: control (no treatment), early iTClamp treatment, late iTClamp treatment, and standard gauze treatment. Survival rate, survival time, and blood loss were the primary endpoints. Physiologic parameters (heart rate, blood pressure, oxygen saturation) were monitored throughout the experiment and blood samples were collected to analyze partial thromboplastin time and fibrinogen. Results: All (100%) of the animals treated with the iTClamp lived through the end of the experiment, compared to 60% in standard gauze treated and 0% of untreated control animals (early and late iTClamp vs. control and standard gauze, Fisher's exact, p = 0.003). Both the early iTClamp and late iTClamp treatment groups survived significantly longer than the untreated control pigs (Mann-Whitney U-test, p < 0.009). External blood loss was significantly lower in animals treated with the iTClamp (early) compared to no treatment (Mann-Whitney U-test, p < 0.008). There was no significant change in physiologic or hematologic parameters between treatment groups. Conclusions: The iTClamp showed statistically significant improvement in survival, survival time, and estimated blood loss when compared to no treatment. This proof-of-concept study demonstrates the potential of the iTClamp to control severe bleeding and prevent blood loss.

Effects of rapid wound sealing on survival and blood loss in a swine model of lethal junctional arterial hemorrhage

“…This device has been shown to effectively control junctional bleeding in a single small study using a swine model. 16 It requires minimal training for appropriate use and has been shown to cause negligible tissue trauma to the skin from its pressure and anchoring needles. 16 Its per-application cost (US $79) is only moderately higher than the current wound-packing standards of Kerlix (US $1) and QuikClot (US $20).…”

“…16 It requires minimal training for appropriate use and has been shown to cause negligible tissue trauma to the skin from its pressure and anchoring needles. 16 Its per-application cost (US $79) is only moderately higher than the current wound-packing standards of Kerlix (US $1) and QuikClot (US $20). The iTClamp can be applied quickly and, if found to be effective, might be considered as a viable option for care-under-fire scenarios.…”

Bridging the Gap: A Novel Method for Hemorrhage Control

“…It has been demonstrated in the literature that the iTClamp is able to control bleeding in any compressible zone [13][14][15][16][17]. This case report adds to that body of knowledge and shows that the iTClamp may be a viable option to DMP or wound packing alone to controlling hemorrhage in junctional/penetrating neck injury, especially when combined with packing.…”

Control of Traumatic Extremity Hemorrhage

“…One study 61 has been published that compared the iTClamp with standard gauze and a control in a swine model of groin injury. Those researchers reported a statistically signifi cant increase in survival when the iTClamp was used and a statistically signifi cant decrease in external blood loss when an iTClamp was applied early compared with when gauze was used.…”

“…However, Filips et al 61 recognized this deficit and suggested further research in jagged wounds, compared with hemostatic dressings, and in coagulopathic patients.…”