RESUMEN
INTRODUCTION: Acute blood loss represents a leading cause of death in both civilian and battlefield trauma, despite the prioritization of massive hemorrhage control by well-adopted trauma guidelines. Current Tactical Combat Casualty Care (TCCC) and Tactical Emergency Casualty Care (TECC) guidelines recommend the application of a tourniquet to treat life-threatening extremity hemorrhages. While extremely effective at controlling blood loss, the proper application of a tourniquet is associated with severe pain and could lead to transient loss of limb function impeding the ability to self-extricate or effectively employ weapons systems. As a potential alternative, Innovative Trauma Care (San Antonio, Texas USA) has developed an external soft-tissue hemostatic clamp that could potentially provide effective hemorrhage control without the aforementioned complications and loss of limb function. Thus, this study sought to investigate the effectiveness of blood loss control by an external soft-tissue hemostatic clamp versus a compression tourniquet. HYPOTHESIS: The external soft-tissue hemostatic clamp would be non-inferior at controlling intravascular fluid loss after damage to the femoral and popliteal arteries in a normotensive, coagulopathic, cadaveric lower-extremity flow model using an inert blood analogue, as compared to a compression tourniquet. METHODS: Using a fresh cadaveric model with simulated vascular flow, this study sought to compare the effectiveness of the external soft-tissue hemostatic clamp versus the compression tourniquet to control fluid loss in simulated trauma resulting in femoral and posterior tibial artery lacerations using a coagulopathic, normotensive, cadaveric-extremity flow model. A sample of 16 fresh, un-embalmed, human cadaver lower extremities was used in this randomized, balanced two-treatment, two-period, two-sequence, crossover design. Statistical significance of the treatment comparisons was assessed with paired t-tests. Results were expressed as the mean and standard deviation (SD). RESULTS: Mean intravascular fluid loss was increased from simulated arterial wounds with the external soft-tissue hemostatic clamp as compared to the compression tourniquet at the lower leg (119.8mL versus 15.9mL; P <.001) and in the thigh (103.1mL versus 5.2mL; P <.001). CONCLUSION: In this hemorrhagic, coagulopathic, cadaveric-extremity experimental flow model, the use of the external soft-tissue hemostatic clamp as a hasty hemostatic adjunct was associated with statistically significant greater fluid loss than with the use of the compression tourniquet.Paquette R, Bierle R, Wampler D, Allen P, Cooley C, Ramos R, Michalek J, Gerhardt RT. External soft-tissue hemostatic clamp compared to a compression tourniquet as primary hemorrhage control device in pilot flow model study. Prehosp Disaster Med. 2019;34(2):175-181.
Asunto(s)
Hemorragia/terapia , Traumatismos de la Pierna/terapia , Medicina Militar , Cadáver , Estudios Cruzados , Tratamiento de Urgencia , Diseño de Equipo , Hemostasis , Humanos , Modelos Anatómicos , Proyectos Piloto , Torniquetes , Resultado del TratamientoRESUMEN
Exsanguinating hemorrhage is a primary cause of battlefield death. The iTClamp is a relatively new device (FDA approval in 2013) that takes a different approach to hemorrhage control by applying mechanism wound closure. However, no previous studies have explored the feasibility of utilizing the iTClamp in conjunction with hemostatic packing. To fill this important gap in the literature, a novel swine model was developed, and a total of 12 trials were performed using QuikClot Combat Gauze or XSTAT sponges in conjunction with the iTClamp to treat arterial injuries through 5 cm or 10 cm skin incisions in the groin, axilla, or neck. First-attempt application success rate, application time, and blood loss were recorded. Hemostasis was achieved on all wounds, though reapplication was required in one Combat Gauze and three XSTAT applications. Application averaged ~50% slower for Combat Gauze (M = 41 seconds, 95%CI: 22-32 seconds) than for XSTAT (M = 27 seconds, 95%CI: 35-47 seconds). XSTAT application was faster than Combat Gauze for each wound location and size. The 10 cm wounds took ~10 seconds (36%) longer to close (M = 27 seconds, 95%CI: 35-47 seconds) than the 5 cm wounds (M = 27 seconds, 95%CI: 35-47 seconds). Blood loss was similar for Combat Gauze (M = 51 mL, 95%CI: 25-76 mL) and XSTAT (M = 60 mL, 95%CI: 30-90 mL). Blood loss was roughly twice as great for 10 cm wounds (M = 73 mL, 95%CI: 47-100 mL) than for 5 cm wounds (M = 38 mL, 95%CI: 18-57 mL). This pilot study supports the feasibility of a novel model for testing the iTClamp in conjunction with hemostatic packing towards controlling junctional hemorrhage.
Asunto(s)
Exsanguinación/tratamiento farmacológico , Hemostáticos/normas , Procedimientos Quirúrgicos Vasculares/instrumentación , Animales , Modelos Animales de Enfermedad , Exsanguinación/prevención & control , Técnicas Hemostáticas/instrumentación , Hemostáticos/uso terapéutico , Proyectos Piloto , Porcinos/lesiones , Procedimientos Quirúrgicos Vasculares/métodos , Procedimientos Quirúrgicos Vasculares/normasRESUMEN
BACKGROUND: Controlling bleeding early in the prehospital and military setting is an extremely important and life-saving skill. Wound clamping is a newly introduced technique that may augment both the effectiveness and logistics of wound packing with any gauze product. As these devices may be inadvertently removed, the potential consequences of such were examined in a simulated, extreme, inadvertent disengagement. METHODS: The wound clamp used was an iTClamp (Innovative Trauma Care; Edmonton, Alberta, Canada) that was applied and forcefully removed (skin-pull) from the skin of both a human cadaver and swine. Sixty skin-pull tests were sequentially performed to measure the pull weight required to remove the device, any potential skin and device damage, how the device failed, and if the device could be re-applied. RESULTS: Observations of the skin revealed that other than the expected eight small needle holes from device application, no other damage to the skin was sustained in 98.3% of cases. Conversely, of the 60 devices pulled, 93.3% of the devices sustained no damage and all could be re-applied. Four (6.7%) of the devices remained in place despite a maximum pull weight >22lb F (pound-force). The mean pull weights for pin bar pull were (lb F ): vertical 9.2 (SD=5.0); perpendicular 2.5 (SD=1.7); and parallel 5.3 (SD=3.1). For the encompassed pull position group, mean pull weights were (lb F ): vertical 5.7 (SD=2.3); perpendicular 3.0 (SD=2.5); and parallel 14.5 (SD=3.5). The overall mean for all groups was 6.7 (SD=5.2). The two main reasons that the iTClamp was pulled off were because the friction lock let go or the needles slipped out of one side of the skin due to the angle of the pull. CONCLUSION: Inadvertent, forcible removal of the iTClamp created essentially no skin damage seen when the wound clamp was forcibly removed from either cadaver or swine models in a variety of positions and directions. Thus, the risks of deployment in operational environments do not seem to be increased. Mckee JL , Lakshminarasimhan P , Atkinson I , LaPorta AJ , Kirkpatrick AW . Evaluation of skin damage from accidental removal of a hemostatic wound clamp (the iTClamp). Prehosp Disaster Med. 2017;32(6):651-656.