Evaluation of the iTClamp 50 in a human cadaver model of severe compressible bleeding.

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.