{"title":"凝血酶-明胶基质与可吸收明胶海绵相比对单侧开门板层成形术术中止血的影响：随机对照试验","authors":"Chengyi Huang, Zhu Chen, Hao Liu, Junbo He, Yiwei Shen, Tingkui Wu, Beiyu Wang","doi":"10.1097/BRS.0000000000005107","DOIUrl":null,"url":null,"abstract":"<p><strong>Study design: </strong>Prospective, randomized, parallel-controlled trial.</p><p><strong>Objective: </strong>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.</p><p><strong>Summary of background data: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 difference = 177.21 mL, 95% confidence interval [CI], 157.88-196.53 mL, t=18.25, P <0.001); the duration of hemostasis, volume of drainage, days of drainage in the TGM group, and maximum decrease in Hb were also significantly less than those in the AGS group ( P <0.01).</p><p><strong>Conclusion: </strong>The hemostatic efficacy of TGM-AGS is better than that of an AGS alone in IBL. TGM-AGS is also superior to an AGS alone in the evaluation of hemostatic efficiency and postoperative bleeding.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":"285-293"},"PeriodicalIF":2.6000,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Effect of Thrombin-gelatin Matrix Compared With Absorbable Gelatin Sponge on Intraoperative Hemostasis in Unilateral Open-door Laminoplasty: A Randomized Controlled Trial.\",\"authors\":\"Chengyi Huang, Zhu Chen, Hao Liu, Junbo He, Yiwei Shen, Tingkui Wu, Beiyu Wang\",\"doi\":\"10.1097/BRS.0000000000005107\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Study design: </strong>Prospective, randomized, parallel-controlled trial.</p><p><strong>Objective: </strong>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.</p><p><strong>Summary of background data: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 difference = 177.21 mL, 95% confidence interval [CI], 157.88-196.53 mL, t=18.25, P <0.001); the duration of hemostasis, volume of drainage, days of drainage in the TGM group, and maximum decrease in Hb were also significantly less than those in the AGS group ( P <0.01).</p><p><strong>Conclusion: </strong>The hemostatic efficacy of TGM-AGS is better than that of an AGS alone in IBL. TGM-AGS is also superior to an AGS alone in the evaluation of hemostatic efficiency and postoperative bleeding.</p>\",\"PeriodicalId\":22193,\"journal\":{\"name\":\"Spine\",\"volume\":\" \",\"pages\":\"285-293\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Spine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/BRS.0000000000005107\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/BRS.0000000000005107","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/29 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
The Effect of Thrombin-gelatin Matrix Compared With Absorbable Gelatin Sponge on Intraoperative Hemostasis in Unilateral Open-door Laminoplasty: A Randomized Controlled Trial.
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 difference = 177.21 mL, 95% confidence interval [CI], 157.88-196.53 mL, t=18.25, P <0.001); the duration of hemostasis, volume of drainage, days of drainage in the TGM group, and maximum decrease in Hb were also significantly less than those in the AGS group ( P <0.01).
Conclusion: The hemostatic efficacy of TGM-AGS is better than that of an AGS alone in IBL. TGM-AGS is also superior to an AGS alone in the evaluation of hemostatic efficiency and postoperative bleeding.
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Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.
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