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.
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Data availability
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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Funding
This study was funded by the Tung Wah Group Hospital Research Fund. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by EP-LN, K-LT and S-LY. The first draft of the manuscript was written by EP-LN and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
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This study received institutional ethics committee approval. Reference number: KW/FR-15–032(83–33).
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Ng, E.PL., Tung, KL., Yip, SL. et al. 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. Eur Spine J 32, 2282–2287 (2023). https://doi.org/10.1007/s00586-023-07748-8
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DOI: https://doi.org/10.1007/s00586-023-07748-8