Evaluation of a Novel Chitosan-Based Hemostatic Spray in a Standard Swine Hemorrhage Model.

BACKGROUND

Chitosan is widely recognized as an effective hemostatic biomaterial, and chitosan-based products are extensively deployed for topical hemorrhage control in military and civilian settings. Nevertheless, existing formulations have limited applicability in austere and challenging environmental conditions. This study compared SEAL™ Hemostatic Wound Spray (SEAL)-the only FDA-cleared chitosan aerosol spray- against CELOX®, a current chitosan-based hemostatic standard.

METHODS

Eight adult male pigs were randomized into two groups: SEAL (n=4) and CELOX (n=4). A 4mm femoral arteriotomy was created. Following 30 seconds of uncontrolled bleeding, SEAL or CELOX was applied, followed by three minutes of gauze compression. Fluid resuscitation with Ringer's Lactate maintained the mean arterial pressure at 60-65mmHg. The animals were monitored for 2.5 hours or until death. Efficacy endpoints included hemorrhage time, blood loss, blood pressure, survival, and a simulated walking test to assess rebleeding. Safety was evaluated by gross necroscopy and histopathology.

RESULTS

No statistically significant differences were observed between SEAL and CELOX in bleeding time, blood loss, mean arterial pressure, and overall survival. Blood hemogram and clotting parameters showed no abnormalities. Gross necropsy and histopathology by a boardcertified pathologist blinded to each animal's study group assignment revealed no tissue or organ damage attributable to either product. No thromboemboli or product residues were detected in samples treated with either product.

CONCLUSION

SEAL demonstrated equivalent efficacy and safety to CELOX for hemorrhage control. As a sprayable formulation with unique properties, SEAL offers several advantages in challenging prehospital environments where use of conventional products is less feasible.