Background : Postoperative bleeding is one of the most important complications of liver surgery. Locally applied pad-type hemostatic products are widely used to control oozing bleeding on the resection surface.

Methods : Stopad (NCbit Inc., Seongnam, Korea) is a pad-type hemostatic agent containing carboxymethyl chitosan and recombinant thrombin-like hemoagulase (rTLH). We conducted a prospective, multicenter (3 institutions), single-blind, randomized, noninferiority study of Stopad vs. Tachosil (Takeda Pharmaceuticals, Tokyo, Japan) in 104 patients who required open hepatic resection. The subjects were randomized 1:1 to either experimental group (Stopad; 53 subjects) or control group (Tachosil; 51 subjects).

Results : The 3-min bleeding control success rate was 92.45% (49/53 subjects) in the experimental group and 90.20% (46/51 subjects) in the control group. The lower bound of the one-sided 97.5% confidence level for the between-group difference in the success rate was −9.82%, which was within the preset noninferiority limit of −22.9%. The 5- and 10-min bleeding control success rates were both 100.00% (53/53 subjects) for the experimental group and were both 98.04% (50/51 subjects) in the control group. 53 adverse events occurred in 29 subjects (54.72%) in the experimental group and 26 adverse events occurred in 17 subjects (33.33%) in the control group. The higher number of adverse events in the experimental group was likely due to a higher proportion of subjects with past medical history. There was no significant difference in the number of adverse device effects.

Conclusions : The hemostatic efficacy of Stopad was noninferior to that of Tachosil in patients undergoing open hepatic resection.