Efficacy and safety analysis of a new hemostatic gelatin matrix for spinal surgery: A randomized controlled study

Abstract

Objective: This study aimed to assess the efficacy and safety of a new hemostatic gelatin matrix for use in spinal surgery.Methods: From September to December 2020, 54 patients from our hospital were recruited and randomly allocated to a test group or a control group using computer-generated randomization codes. In the test group, the new hemostatic gelatin matrix was used; in the control group, the Surgiflo™ Hemostatic Matrix was used. All operations for both groups were performed by a senior physician, and the following measures were recorded for comparison: (i) rates of successful hemostasis at 5 min; (ii) time to hemostasis; (iii) blood pressure (BP); (iv) red blood (RBC) cell count; and (v) hemoglobin (Hb) levels in the preoperative period, 1st to 2nd postoperative days, and 42nd postoperative day. Adverse events following surgery were also compared. Results: All patients were followed up for at least 6 weeks. In the test group, 24 and 2 cases achieved and did not achieve hemostasis within 5 min, respectively. In the control group, 23 and 2 cases achieved and did not achieve hemostasis within 5 min, respectively. There was no statistical difference between the two groups (P = 0.967). The time to hemostasis, BP, RBC, and Hb in the preoperative period, on the 1st and 2nd postoperative days, and 42nd postoperative day also showed no significant differences between groups (P > 0.05).Conclusion: The new hemostatic gelatin matrix has the same efficacy and safety as that of Surgiflo™ Hemostatic Matrix.