Evaluating the Efficacy and Safety of Hemofence (Thorombin Cross-linked Sodium Hyaluronate Gel Matrix) in Hemostasis for Intractable Exudative Bleeding in Spinal Surgery: A Multicenter, Randomized, Phase III Clinical Trial

Objective: To demonstrate the non-inferiority of the novel hemostatic agent, Hemofence ® (BMI Korea Co. Ltd., Jeju Korea, thrombin cross-linked sodium hyaluronate gel matrix) compared to the established agent, Floseal Hemostatic Matrix (Baxter, thrombin-gelatin matrix) in achieving hemostasis for spinal surgeries, with secondary objectives to assess additional efficacy and safety.Methods: This clinical trial was a multicenter, randomized, subject-blinded, active-controlled, parallelgroup, phase 3 study.Investigational drugs were administered to the first and second bleeding sites of each participant (or only to the first site if a second site was absent), evaluating hemostasis success rate within 10 minutes and the time to achieve hemostasis.Subsequent visits were conducted for safety assessments.For non-inferiority test, a 97.5% one-sided confidence interval was used; the test group was deemed non-inferior if the lower limit exceeded -10%.Results: This trial showed a 97.10% success rate in the test group and 96.05% in the control group for primary efficacy.The 95% confidence interval (-4.90%, 7.44%) confirmed the test drug's noninferiority.Time to hemostasis showed no significant difference between groups.All adverse events, adverse drug reactions, and serious adverse events were statistically similar between groups (p=1.0000,p=0.2427, and p=0.9663, respectively). Conclusion:A novel hemostatic agent, Hemofence ® , demonstrated an efficacy and safety profile comparable to that of Floseal.