A Randomized, Multi Center, Double Blind and Active-Controlled Clinical Study to Evaluate and Compare the Efficacy and the Safety in Preventing Adhesion Formation Between BNCH-202 And Guardix-SOL after Operation for Disc Herniation or Spinal Stenosis

Abstract

Objective: Peridural fibrosis may cause failed back syndrome and the presence of fibrosis renders reoperations risky. Therefore, preventing the adhesion of scar tissue to the dura and nerve root is one of the issues in spinal surgery. Thus, the purpose of this study is to evaluate and compare the efficacy and the safety between two anti-adhesive agents, BNCH-202 (Korea BNC Inc, Daegu, Korea) and Guardix-SOL (Hanmi, Seoul, Korea). Methods: Sixty eight patients were enrolled in this study. To evaluate and compare the efficacy in preventing epidural adhesion formation and the safety in human laminotomy models, the two barriers tested were either BNCH-202 or Guardix-SOL (gel/film combination). Clinical evaluation was performed at 0, 6 and 12 weeks to assess pain and functional outcome. The patients were also assessed radiographically with postoperative magnetic resonance imaging (MRI) to evaluate the presence of perinueral scar and adhesion Results: There was no statistically significant difference between two biologic barriers in terms of the safety issue, clinical and radiological efficacy. There were no significant differences between the BNCH-202 group and the control group on the preoperative ODI and VAS scores. In general, the ODI and VAS scores decreased in both groups at all the time points. At the 6 week and 12 week time point, the VAS scores for back pain/ leg pain and the ODI scores in both groups were lower than the preoperative score in each group (P<0.01). And at the 12-week time point, the peridural scar scores were assessed in both groups. The mean value of the peridural scar score in BNCH-202 group was not inferior to the mean value of that in Guardix-SOL group. Conclusion: The results demonstrated that BNCH-202 gel is as effective as Guardix-SOL in reducing posterior dural adhesions in the spine with no apparent safety issues. It can improve patients’ postoperative clinical outcome.