Hemostatic efficacy and safety of oxidized regenerated cellulose hemostatic material in a multi-organ bleeding porcine model

Oxidized regenerated cellulose (ORC) is a widely used absorbable hemostatic agent, but comparative data on its efficacy across different bleeding scenarios remain limited. This study compared the hemostatic efficacy, tissue compatibility, and safety of a domestically produced absorbable ORC (StypCel™) with an imported counterpart (Surgicel ® Fibrillar™) in minipig models of Liver, Gastric wall, and Mesentery bleeding. Sixteen male Bama minipigs were randomly assigned to the Liver bleeding model ( n = 8) or the gastrointestinal model ( n = 8). Within each model, animals were further allocated to the StypCel™ group ( n = 4) or the Surgicel ® Fibrillar™ group ( n = 4), with three bleeding sites created per animal per organ. Bleeding models were established for each organ, and outcomes including 10‑s blood loss, time to hemostasis, intraoperative blood loss, hematology, liver and kidney function, coagulation parameters, and histological changes were assessed. Both materials exhibited three‑dimensional porous network structures, with StypCel™ showing significantly finer fibers (9.82 ± 0.93 μm vs. 20.59 ± 1.88 μm, P < 0.001). In the Liver, Gastric wall, and Mesentery bleeding models, no significant differences were observed between groups in time to hemostasis ( P = 0.8759, P = 0.1578, and P = 0.9632, respectively), intraoperative blood loss ( P = 0.0805, P = 0.7673, and P = 0.4678, respectively), or any hematological, biochemical, or coagulation parameters at all time points (all P > 0.05). Histological analysis revealed similar degradation and absorption profiles, with inflammation essentially resolved by week 4 in both groups. StypCel™ demonstrated hemostatic efficacy and safety comparable to those of Surgicel ® Fibrillar™ across multiple bleeding models, supporting its use as an effective alternative.