Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models.

Purpose: Currently available hemostatic pads are effective in treating oozing bleeds, but otherwise ineffective in more severe bleeding. This study investigates the hemostatic efficacy of a new hemostatic pad with advanced sealing properties using protein-reactive polyethylene glycol-coated collagen (PCC, Hemopatch) versus an oxidized regenerated cellulose (ORC, Tabotamp/Surgicel Original) in a leporine arterial bleeding model of vascular reconstruction and a porcine hepatic model of general surgery. Methods: In both models, paired lesions were created and treated according to a randomized scheme and evaluated up to 10 min after application (40 lesions/group/model). Arterial needle holes were created in the femoral arteries of anesthetized rabbits and hepatic lesions were created into hepatic parenchyma of anesthetized pigs. Both models were heparinized to mimic clinical comorbidity. Results: In the leporine vascular surgical model, PCC provided superior hemostatic success compared to ORC at 2 min (Odds Ratio of Success: 85, 95% CI: 25.8–282) and similar hemostatic success at 10 min. In the porcine hepatic model, PCC provided superior hemostatic success compared to ORC at 2 (98 vs 55%, P < 0.001), 3 (93 vs 65%, P < 0.001), 4 (98 vs 68%, P < 0.001) and 5 min (95 vs 80%, P < 0.001), but similar hemostatic success at 8 and 10 min. Discussion: PCC provided 75.4% greater hemostatic success at 2 min in the arterial model and was at least 100 times more likely to be hemostat effective at 2 min in the hepatic model than ORC. Conclusions: PCC provided faster hemostasis than ORC in a vascular and hepatic surgical model with impaired coagulation.