Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial

Abstract

Objective: When common hemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local hemostatic agents are used. We aimed to evaluate the hemostatic efficacy and safety of CollaStat (Dalim Tissen Co. Ltd., Seoul, Korea), a novel thrombin-containing, collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal (Baxter Healthcare, Deerfield, Illinois, USA).

Methods: We performed a randomized controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat) or a control group (use of Floseal). We compared successful haemostasis rate, time to hemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the 2 groups.

Results: The hemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal was greater than the prespecified noninferiority margin of -13%. There were no statistically significant differences at the 5% level in hemostasis time, number of hemostatic agents used, hospitalization period, and amount of drainage between the 2 groups. Also, there was no incidence of medical device-related serious adverse events or adverse events in both groups.

Conclusions: The hemostatic efficacy and safety of CollaStat were found to be noninferior to those of Floseal. Therefore CollaStat can be safely and effectively used in spinal surgery.

Keywords: Collagen; Hemostatic agent; Spinal surgery; Thrombin.