Does prophylactic use of topical gelatin-thrombin matrix sealant affect postoperative drainage volume and hematoma formation following microendoscopic spine surgery? A randomized controlled trial

Takami, Masanari; Yoshida, Munehito; Minamide, Akihito; Hashizume, Hiroshi; Yukawa, Yasutsugu; Nakagawa, Yukihiro; Iwasaki, Hiroshi; Tsutsui, Shunji; Nagata, Keiji; Taiji, Ryo; Nishi, Hideto; Schoenfeld, Andrew J.; Simpson, Andrew K.; Yamada, Hiroshi

doi:10.1016/j.spinee.2020.11.004

Cited by 10 publications

(10 citation statements)

References 28 publications

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“…On the other hand, Takami et al reported that the area of hematoma measured by MRI 3 to 5 days after surgery was not significantly different, irrespective of whether GTMS was used prophylactically. 14 Therefore, intraoperative GTMS use, whether used therapeutically or prophylactically, may not necessarily reduce PSEH formation or the rate of revision surgery. The present study demonstrated a smaller drainage volume (reduced by 18.2 g on average) in the GTMS-used group by 2 days after surgery.…”

Section: Discussionmentioning

confidence: 99%

“…However, in another recent randomized controlled trial (RCT) by Takami et al, the prophylactic application of GTMS during MEL did not substantially affect the extent of PSEH, as assessed both by direct measurement of drainage and postoperative surveillance MRI. 14 In our clinical practice, with the increasing average age of patients undergoing microendoscopic spinal surgery, 15 the preoperative use of antiplatelet drugs, anticoagulants, and vasodilating drugs is more frequent. Where possible, these medications are discontinued before surgery, and drains are routinely left in place after MEL in order to prevent PSEH.…”

Section: Introductionmentioning

confidence: 99%

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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

Nomura¹,

Yoshida²,

Okada³

et al. 2021

Global Spine Journal

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Nomura¹,

Yoshida²,

Okada³

et al. 2021

Global Spine Journal

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“…Microendoscopy-assisted surgery is another procedure associated with technical difficulty, where surgeons have limited access to the source of bleeding. The usefulness of TGM in minimally invasive surgery has been reported, and two studies have described its usage as being associated with a significant reduction of risk of postoperative epidural hematoma, [ 7 , 8 ] while a more recent randomized controlled trial found no marked benefit in preventing postoperative epidural hematoma, thereby discouraging the routine usage of TGM following microendoscopic surgery [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

Predictors for hemostatic thrombin-gelatin matrix usage in spine surgery: a multicenter observational study

Kato

Miyahara²,

Matsubayashi³

et al. 2023

BMC Musculoskelet Disord

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Study design A prospective cohort study. Objectives Thrombin-gelatin matrix (TGM) is a rapid and potent hemostatic agent, but it has some limitations, including the cost and its preparation time. The purpose of this study was to investigate the current trend in the use of TGM and to identify the predictors for TGM usage in order to ensure its proper use and optimized resource allocation. Methods A total of 5520 patients who underwent spine surgery in a multicenter study group within a year were included in the study. The demographic factors and the surgical factors including spinal levels operated, emergency surgery, reoperation, approach, durotomy, instrumented fixation, interbody fusion, osteotomy, and microendoscopy-assistance were investigated. TGM usage and whether it was routine or unplanned use for uncontrolled bleeding were also checked. A multivariate logistic regression analysis was used to identify predictors for unplanned use of TGM. Results Intraoperative TGM was used in 1934 cases (35.0%), among which 714 were unplanned (12.9%). Predictors of unplanned TGM use were female gender (adjusted odds ratio [OR]: 1.21, 95% confidence interval [CI]: 1.02–1.43, p = 0.03), ASA grade ≥ 2 (OR: 1.34, 95% CI: 1.04–1.72, p = 0.02), cervical spine (OR: 1.55, 95% CI: 1.24–1.94, p < 0.001), tumor (OR: 2.02, 95% CI: 1.34–3.03, p < 0.001), posterior approach (OR: 1.66, 95% CI: 1.26–2.18, p < 0.001), durotomy (OR: 1.65, 95% CI: 1.24–2.20, p < 0.001), instrumentation (OR: 1.30, 1.03–1.63, p = 0.02), osteotomy (OR: 5.00, 2.76–9.05, p < 0.001), and microendoscopy (OR: 2.24, 1.84–2.73, p < 0.001). Conclusions Many of the predictors for unplanned TGM use have been previously reported as risk factors for intraoperative massive hemorrhaging and blood transfusion. However, other newly revealed factors can be predictors of bleeding that is technically challenging to control. While routine usage of TGM in these cases will require further justification, these novel findings are valuable for implementing preoperative precautions and optimizing resource allocation.

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“…Lastly, we observed no clinical effect of GTMS on drain output in this study, which was consistent with previous reports. 15,23 Helenius et al 15 revealed that a GTMS treatment group had a mean of only 6 mL less blood loss postoperatively, whereas Takami et al 23 reported that GTMS after minimally invasive decompressions in microendoscopic surgery did not provide any clinical benefit in terms of reducing postoperative blood loss. Therefore, GTMS is effective in decreasing intraoperative blood loss, but may not improve blood loss afterward.…”

Section: Discussionmentioning

confidence: 99%

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

Mimura¹,

Ikegami²,

Uehara³

et al. 2023

Spine

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Study Design. Retrospective cohort study with interrupted time series analysis. Objective. To examine the clinical effectiveness of gelatinthrombin matrix sealant (GTMS) on blood loss reduction after adolescent idiopathic scoliosis (AIS) surgery. Summary of Background Data. The real-world effectiveness of GTMS on blood loss reduction in AIS surgery has not been determined. Patients and Methods. The medical records of patients receiving AIS surgery were retrospectively collected during a period before GTMS approval at our institution (

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Does prophylactic use of topical gelatin-thrombin matrix sealant affect postoperative drainage volume and hematoma formation following microendoscopic spine surgery? A randomized controlled trial

Cited by 10 publications

References 28 publications

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

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

Predictors for hemostatic thrombin-gelatin matrix usage in spine surgery: a multicenter observational study

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

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