The iTClamp controls junctional bleeding in a lethal swine exsanguination model.

Area of Science:

• Trauma care and emergency medicine
• Surgical device innovation
• Hemorrhage control strategies

Background:

• Severe hemorrhage is a leading cause of preventable death.
• Existing prehospital interventions for external bleeding have limitations.
• A novel temporary wound closure device, the iTClamp, has been developed to control hemorrhage in compressible zones.

Purpose of the Study:

• To evaluate the effectiveness of the iTClamp device in controlling severe external hemorrhage.
• To assess the iTClamp's ability to manage major vascular injury in the groin.
• To compare the iTClamp to standard gauze treatment and no treatment in a swine model.

Main Methods:

• Twenty Yorkshire-cross male swine underwent femoral artery and vein excision to simulate groin injury.
• Animals were randomized into four groups: control, early iTClamp, late iTClamp, and standard gauze.
• Primary endpoints included survival rate, survival time, and blood loss; physiological and hematological parameters were monitored.

Main Results:

• 100% survival was observed in both early and late iTClamp treatment groups, compared to 60% with gauze and 0% in controls (p = 0.003).
• iTClamp treated groups showed significantly longer survival times and reduced blood loss compared to controls (p < 0.009 and p < 0.008, respectively).
• No significant changes in physiological or hematological parameters were noted between groups.

Conclusions:

• The iTClamp demonstrated a statistically significant improvement in survival and reduction of blood loss compared to no treatment.
• This study serves as proof-of-concept for the iTClamp's potential in managing severe external bleeding.
• The device shows promise for controlling hemorrhage in critical prehospital scenarios.