Chronic safety assessment of hemostatic self-expanding foam: 90-day survival study and intramuscular biocompatibility.

Abstract

Noncompressible hemorrhage is a significant cause of preventable death in trauma, with no effective presurgical treatments. We previously described the efficacy and 28-day safety of a self-expanding hemostatic foam in swine models. We hypothesized that the 28-day results would be confirmed at a second site and that results would be consistent over 90 days. Finally, we hypothesized that the foam material would be biocompatible following intramuscular implantation. Foam treatment was administered in swine following a closed-cavity splenic injury. The material was explanted after 3 hours, and the animals were monitored to 28 days (n = 6) or 90 days (n = 4). Results were compared with a control group with injury alone (n = 6 at 28 days, n = 3 at 90 days). In a separate study, foam samples were implanted in rabbit paravertebral muscle and assessed at 28 days and 90 days relative to a Food and Drug Administration-approved polyurethane mesh (n = 3 per group). All animals survived the acute phase of the study, and the foam animals required enterorrhaphy. One animal developed postoperative ileus and was euthanized; all other animals survived to the 28-day or 90-day end point without clinically significant complications. Histologic evaluation demonstrated that remnant particles were associated with a fibrotic capsule and mild inflammation. The foam was considered biocompatible in 28-day and 90-day intramuscular implant studies. Foam treatment was not associated with significant evidence of end-organ dysfunction or toxicity at 28 days or 90 days. Remnant foam particles were well tolerated. These results support the long-term safety of this intervention for severely bleeding patients.