Effectiveness of a Gelatin–Thrombin Matrix Sealant (Floseal®) for Reducing Blood Loss During Microendoscopic Decompression Surgery for Lumbar Spinal Canal Stenosis: A Retrospective Cohort Study

Abstract

Study Design: Retrospective cohort study. Objectives: To investigate the effectiveness and safety of a gelatin–thrombin matrix sealant (GTMS) during microendoscopic laminectomy (MEL) for lumbar spinal canal stenosis (LSCS). Methods: This study included 158 LSCS cases on hemostasis-affecting medication who underwent MEL by a single surgeon between September 2016 and August 2020. Patients were divided into 2 groups depending on whether GTMS was used (37 cases, Group A) or not (121 cases, Group B). Perioperative data related to bleeding or postoperative spinal epidural hematoma (PSEH) was investigated. Clinical outcomes were evaluated using the Japanese Orthopedic Association (JOA) score for low back pain. Results: The mean intraoperative blood loss per level was greater in Group A (26.0 ± 20.3 g) than in Group B (13.6 ± 9.0 g), whereas the postoperative drainage volume was smaller in Group A (79.1 ± 42.5 g) than in Group B (97.3 ± 55.6 g). No revision surgeries for PSEH were required in Group A, while 2 (1.7%) revisions were required in Group B ( P = .957). The median JOA score improved significantly from the preoperative period to 1-year postoperatively in both Group A and B (total score, 16.0-23.5 and 17.0-25.0 points, respectively). Conclusions: The use of GTMS during MEL for LSCS may be associated with a reduction in postoperative drainage volume. The revision rate for PSEH was not affected significantly by the use of GTMS. Clinical outcomes (represented by the JOA score) were significantly improved after the surgery, regardless of GTMS use during MEL.

Effect of Thrombin-Containing Local Hemostatics on Postoperative Spinal Epidural Hematoma in Biportal Endoscopic Spinal Surgery

“…The study’s primary objective was to determine whether TCLH use during central stenosis or HNP with BESS is associated with a difference in the incidence of symptomatic and morphometric POSEH. In this study, the rates of symptomatic POSEH were 4.6% and 9.5% in groups A and B, respectively, which was higher than those in other studies [ 5 , 9 ]. In other studies, symptomatic POSEH cases were diagnosed only when severe paralysis occurred [ 5 , 9 ].…”

The efficacy and safety of thrombin-based flowable hemostatic agents in spine surgery: a protocol for systematic review and meta- analysis

“…Ma et al [28] found that Surgi o can signi cantly decrease intraoperative bleeding volume, total volume of intraoperative bleeding. Floseal differs from Surgi o in that it is prepared from bovine-derived gelatin crosslinked with methacrylic anhydride [20,24,29] . A retrospective analysis of the thousands of patient data was carried out by Ramirez et al [33] and found that Floseal can reduce transfusion requirements, bleeding complications.…”

“…Ma et al [28] performed a RCT to explore the e cacy of Surgi o, and found that Surgi o could reduce blood loss in during hemostatic process in addition to the amount of blood loss, autologous blood transfusion and surgical time, and no adverse events are reported. Nomura et al [29] and Chen et al [30] Floseal could signi cantly decrease the intraoperative blood loss and postoperative drainage volume and did not increase the risks of adverse events. Therefore, the e cacy, especially in the safety of Floseal and Surgi o in spine surgery still remain unknown.…”

Real-World Effectiveness of Gelatin-Thrombin Matrix Sealant on Blood Loss in Adolescent Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

“…Numerous studies support the efficacy of GTMS across several surgical fields, [8][9][10][11][12][13][14] including spinal surgery. 15,16 Helenius et al 15 reported in their randomized clinical trial that GTMS could reduce intraoperative blood loss in patients undergoing posterior spinal fusion for AIS. However, the intervention was not blinded to the surgeons, and the trial was limited to experimental situations and rigorously conducted for all patients in the intervention group.…”

“…Among them, gelatin-thrombin matrix sealant (GTMS) has become well-known in recent years owing to its relative ease of application and safety. Numerous studies support the efficacy of GTMS across several surgical fields, 8–14 including spinal surgery 15,16 . Helenius et al 15 reported in their randomized clinical trial that GTMS could reduce intraoperative blood loss in patients undergoing posterior spinal fusion for AIS.…”