A prospective randomised controlled trial evaluating prophylactic Floseal, a gelatin and thrombin-based haemostatic matrix, in postoperative drain output and blood transfusion in transforaminal lumbar interbody fusion surgery

Abstract

Purpose: To evaluate the prophylactic use of Floseal in reducing postoperative blood loss in patients undergoing Transforaminal Lumbar Interbody Fusion (TLIF). TLIF is a lumbar spine decompression and fusion procedure with potential for postoperative blood loss. Prophylactic application of Floseal, a gelatin and thrombin-based haemostatic matrix to the surgical wound before closure was shown to be effective in reducing postoperative drain output in anterior cervical discectomy and fusion. This study postulated that prophylactic use of Floseal before wound closure would reduce postoperative blood loss in patients who underwent TLIF.

Methods: Randomised controlled trial comparing prophylactic use of Floseal and control in patients undergoing single level or two-level TLIF. Primary outcomes included postoperative drain output within 24 h and postoperative transfusion rate. Secondary outcomes included days of drain placement, length of stay and haemoglobin level.

Results: A total of 50 patients was recruited. Twenty six patients were allocated to the Floseal group and 24 were allocated to the control group. There were no baseline characteristic differences between the groups. There were no statistically significant differences in primary outcomes which included postoperative drain output within 24 h and postoperative transfusion rate between patients who received prophylactic Floseal and control. There were no statistically significant differences in secondary outcomes which included haemoglobin level, days of drain placement and length of stay between the two groups.

Conclusion: Prophylactic use of Floseal was not shown to reduce postoperative bleeding in single level or two-level TLIF.

Keywords: Floseal; Fusion; Haemostasis; Lumbar; TLIF.