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The Effect of Thrombin-gelatin Matrix Compared With Absorbable Gelatin Sponge on Intraoperative Hemostasis in Unilateral Open-door Laminoplasty

作者:Chengyi Huang, Chen Zhu, Hao Liu, Junbo He, Yiwei Shen, Tingkui Wu, Beiyu Wang · 发表于:Spine · 年份:2024 · DOI:10.1097/brs.0000000000005107 · 被引用次数:2 · 研究领域:Hemostasis and retained surgical items、Cervical and Thoracic Myelopathy、Spinal Hematomas and Complications

STUDY DESIGN: Prospective, randomized, parallel-controlled trial. OBJECTIVE: The primary aim of this study was to determine whether thrombin-gelatin matrix (TGM) combined with an absorbable gelatin sponge (AGS) could more greatly reduce intraoperative blood loss (IBL) in unilateral open-door laminoplasty than the sole use of an AGS could. The secondary aims were to evaluate the hemostatic efficiency, amount of postoperative bleeding, and safety of the application of TGM combined with an AGS. SUMMARY OF BACKGROUND DATA: IBL during cervical laminoplasty is substantial and is a proper indication for the application of hemostatic agents. However, we are unaware of any clinical trials on the application of TGM and an AGS in posterior cervical spine surgery. METHODS: A total of 80 consecutive patients who underwent unilateral open-door laminoplasty were enrolled from September 2020 to March 2022. Patients were randomized into 2 groups, the TGM-AGS group and the AGS group, with 40 patients in each group. The primary outcome was IBL. Other outcomes included the duration of operation, duration of hemostasis, duration of drainage, maximum decrease in hemoglobin (Hb), length of hospital stay, volume of drainage, number of drainage days, occurrence of adverse events, coagulation indicators, and patient-reported outcome measures (PROMs). RESULTS: The mean IBL for patients in the TGM-AGS group (75.22 ± 21.83 mL) was significantly lower than that in the AGS group (252.43 ± 57.39 mL) (mean d...