From Innovative Trauma Care, Inc. (K.M., D.F., I.A.), Edmonton, Alberta; and Department of Surgery, Faculty of Medicine, University of Manitoba (S.L.), Winnipeg, Manitoba, Canada.
J Trauma Acute Care Surg. 2014 Mar;76(3):791-7. doi: 10.1097/TA.0000000000000043.
Uncontrolled hemorrhage is a significant cause of preventable death. The iTClamp 50 is a temporary wound closure device designed to control bleeding within seconds of an injury. This study evaluates the ability of the iTClamp to control compressible bleeding in a human cadaver model.
Sterile water was pumped through the major arteries to mimic blood flow. Full-thickness, elliptical segments of skin were excised; arteriotomies or complete transections were performed on the major arteries in the thigh (distal femoral), groin (common femoral), neck (carotid), and arm (brachial). Scalp wounds were created by making a 4.4-cm linear incision to the level of the bone. Fluid losses from the wounds were compared with and without the iTClamp applied and with and without movement of the cadaver. Angiographic images of pressure-injected contrast were obtained of the neck and groin wounds. Hematoma volumes and needle penetration depth into the skin were measured.
In all wounds tested, application of the iTClamp significantly reduced fluid loss in all wounds studied (p < 0.05), and movement of the cadaver did not affect the function of the iTClamp. For example, in one groin wound, the average fluid loss during 1 minute was reduced from 728.4 ± 79.3 mL to 5.6 ± 3.4 mL. Distal flow was maintained during application of the iTClamp, as illustrated in angiographic images obtained of the iTClamp applied to the neck and groin wounds. The average needle penetration depth into the skin was 4.21 ± 0.02 mm; furthermore, the iTClamp did not cause any visible skin damage or skin tearing.
The iTClamp is effective at controlling fluid loss from open wounds within multiple compressible areas. The iTClamp does not occlude distal flow, and aside from small needle punctures, there was no other visible skin damage or skin tearing.
无法控制的出血是可预防死亡的主要原因。iTClamp 50 是一种临时伤口闭合装置，旨在受伤后几秒钟内控制出血。本研究评估了 iTClamp 在人体尸体模型中控制可压缩性出血的能力。
通过主要动脉泵送无菌水以模拟血流。切除全层椭圆形皮肤段；在大腿（股骨远端）、腹股沟（股总动脉）、颈部（颈动脉）和手臂（肱动脉）上进行动脉切开术或完全横断。头皮伤口通过在骨平面进行 4.4 厘米的线性切口来创建。比较了施加和不施加 iTClamp 以及尸体移动时的伤口液体损失。对颈部和腹股沟伤口进行了压力注射对比剂的血管造影图像获取。测量血肿体积和针穿透皮肤的深度。
在所有测试的伤口中，应用 iTClamp 可显著减少所有研究伤口的液体损失（p<0.05），并且尸体的移动不影响 iTClamp 的功能。例如，在一个腹股沟伤口中，1 分钟内的平均液体损失从 728.4±79.3 毫升减少到 5.6±3.4 毫升。在应用 iTClamp 期间保持了远端血流，如应用于颈部和腹股沟伤口的 iTClamp 获得的血管造影图像所示。皮肤的平均针穿透深度为 4.21±0.02 毫米；此外，iTClamp 不会造成任何可见的皮肤损伤或皮肤撕裂。
iTClamp 可有效控制多个可压缩区域的开放性伤口的液体损失。iTClamp 不会阻塞远端血流，除了小的针穿刺外，没有其他可见的皮肤损伤或皮肤撕裂。
