Efficacy and Safety of a Bioinspired Chitosan-Catechol/Gelatin Hemostatic Patch vs. TachoSil in Hepatectomy: A Randomized Noninferiority Trial

초록

Background/Objectives: Topical hemostatic biomaterials are used to control diffuse parenchymal bleeding during hepatectomy. TachoSil is a widely used standard fibrin sealant patch. We evaluated the efficacy and safety of InnoSEAL Plus DL, a novel bioinspired absorbable chitosan-catechol/gelatin hemostatic patch, compared with TachoSil. Methods: This multicenter, randomized, single-blind, active-controlled, parallel-group noninferiority trial enrolled adults undergoing hepatectomy who had persistent oozing from the hepatic transection surface despite primary hemostasis. Participants were randomized in a 1:1 ratio to receive InnoSEAL Plus DL or TachoSil. The primary endpoint was hemostatic success within 3 min of application, with a prespecified noninferiority margin of -19.4 percentage points (pp). Safety was assessed up to 30 days postoperatively. Results: Ninety patients were randomized (45 per group). In the per-protocol population, 3 min hemostatic success was achieved in 100.0% of both the InnoSEAL Plus DL (43/43) and TachoSil (41/41) groups. The risk difference was 0.0 pp, and the lower bound of the one-sided 97.5% confidence interval was -8.2 pp, confirming noninferiority. The mean time to hemostasis was similar between groups (1.2 vs. 1.3 min), and no intraoperative rebleeding occurred. Adverse events were reported in 78/90 patients (86.7%) and serious adverse events in 6/90 (6.7%); the latter were typical post-hepatectomy events unrelated to the study devices. No deaths were reported. Conclusions: InnoSEAL Plus DL was noninferior to TachoSil for achieving rapid intraoperative hemostasis during hepatectomy, with no unexpected safety concerns. This bioinspired hemostatic patch is an effective alternative to fibrin sealant, without the use of human-derived proteins.

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