Evaluation of the Performance of StypCel^TM Absorbable Hemostat for Intraoperative Hemorrhage Control in Neurosurgery:...

Background and Objectives: Intraoperative bleeding during neurosurgical procedures poses a significant risk by increasing morbidity and mortality, obscuring the surgical field and prolonging operative time and hospitalization. Effective hemostasis is therefore essential, frequently necessitating the use of topical hemostatic agents. This study aimed to evaluate the performance of a plant-derived oxidized regenerated cellulose (ORC) hemostatic agent StypCel™ Absorbable Hemostat (Medprin Regenerative Medical Technologies Co., Ltd.) in various neurosurgical interventions, including intracranial tumor resections, spinal surgeries, trigeminal neuralgia operations, cerebrospinal fluid fistula repair and ventriculoperitoneal shunt implantation. The study aimed to assess its performance in these procedures due to the high risk of intraoperative bleeding and the challenges of achieving hemostasis in delicate neural structures. Materials and Methods: This prospective, single-arm clinical study included 46 patients who underwent neurosurgical procedures at three neurosurgerical clinics in Riga, Latvia. The primary endpoint was the rate of effective bleeding control achieved within 5 min of StypCel™ application. Safety assessments included monitoring for central nervous system infections (CNSI), intracranial granuloma formation, new-onset neurological deficits, seizures, anaphylactic reactions or device malfunction. All adverse events (AEs) and serious adverse events (SAEs) were documented during the postoperative follow-up. Results: The cohort consisted of 46 patients (29 females and 17 males), including 20 with neoplastic intracranial lesions and 26 with other neurosurgical pathologies. Effective bleeding control within 5 min was achieved in 93.5% of cases (95% CI: 82.1-98.6%). In three patients, bleeding control exceeded 5 min due to unexpected arterial hemorrhage encountered during intracranial tumor resection. No device-related AEs, SAEs, CNSIs or granuloma formations were reported throughout the follow-up period. Conclusions: The findings demonstrate that StypCel™ Absorbable Hemostat is a safe and effective adjunct for achieving intraoperative hemostasis in neurosurgical procedures. Its favorable safety profile and high hemostatic success rate support its clinical utility, particularly for controlling low-pressure venous or capillary bleeding. Further comparative and long-term studies are warranted to validate these results in broader surgical settings.