The hemostatic effect of traditional class Ⅲ hemostatic powder and aggregate absorbable hemostat in surgeries: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

DA Xi’ao ^1,2 , GUO Qiong ^1,3 , XIE Yanlin ^1,4 , GU Xianlin ^1,5 , LONG Youlin ^1,5 ,  LI Zhengchi ^5,6 ,  HUANG Jin ¹ ,  DU Liang ^1,3,5,6

1. Innovation Institute for Integration of Medicine and Engineering, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
2. School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, P. R. China;
3. West China Medical Publishers, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
4. West China School of Public Health, Sichuan University, Chengdu 610041, P. R. China;
5. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, P. R. China;
6. Center for Education of Medical Humanities, West China Hospital of Sichuan University, Chengdu 610041, P. R. China;

Corresponding author：

LI Zhengchi, Email: zhengchili@scu.edu.cn; HUANG Jin, Email: michael_huangjin@163.com; DU Liang, Email: duliang0606@vip.sina.com

Keywords：

Surgery; Traditional class Ⅲ hemostatic powder; Aggregate absorbable hemostat; Hemostatic effect; Systematic review

DOI：

10.7507/1672-2531.202502041

Video：

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Objective To systematically review the hemostatic effect of traditional class Ⅲ hemostatic powder and aggregate absorbable hemostat in surgeries. Methods The PubMed, Embase, CENTRAL, CNKI, VIP and WanFang Data databases were electronically searched to collect controlled studies related to the objectives from inception to September 18^th, 2023. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was then performed by using RevMan 5.3 software. Results A total of 7 randomized controlled trials, 5 cohort studies and 9 animal experiments were included. The results of analysis showed that the group with traditional class Ⅲ hemostatic powder or aggregate absorbable hemostat had a higher hemostatic success rate and shorter hemostatic time than those with no hemostatic material in animal surgeries. And the group with aggregate absorbable hemostat had a higher 10 min hemostatic success rate than those with traditional hemostatic measures. The application of traditional class Ⅲ hemostatic powder in human cardiothoracic surgeries shortened the hemostatic time and reduced drainage after surgeries, but caused more blood loss during knee arthroplasties. Aggregate absorbable hemostat caused less blood loss than traditional hemostatic measures in human hip arthroplasties, and the 5 min and 10 min success rates of aggregate absorbable hemostat group were not worse than those of hemostatic gauze. Conclusion Current evidence shows that the hemostatic effect of both traditional class Ⅲ hemostatic powder and aggregate absorbable hemostat are better than that of no hemostatic material in animal and human surgery, but the comparison results between the two and with other hemostatic measures are still not clear. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.

1.	Montazerian H, Davoodi E, Baidya A, et al. Engineered hemostatic biomaterials for sealing wounds. Chem Rev, 2022, 122(15): 12864-12903.
2.	Bloom JA, Foroutanjazi S, Erlichman Z, et al. The use of hemostatic agents to decrease bleeding complications in breast cancer surgery. Am Surg, 2023, 89(3): 395-400.
3.	Gómez-Ramírez S, Bisbe E, Shander A, et al. Management of perioperative iron deficiency anemia. Acta Haematol, 2019, 142(1): 21-29.
4.	Falcone V, Krotka P, Deutschmann C, et al. Use of polysaccharide hemostatic agent (HaemoCer™) in breast cancer surgery to reduce postoperative complications: a randomised controlled trial. Int Wound J, 2023, 20(4): 925-934.
5.	Matonick JP, Hammond J. Hemostatic efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a heparinized swine spleen incision model. J Invest Surg, 2014, 27(6): 360-365.
6.	冯靖祎, 黄进, 吴航. 医疗机构止血材料管理专家共识. 中国医院建筑与装备, 2021, 22(7): 19-28.
7.	舍浪浪, 毛琳, 宋成利. 外科止血粉的微观结构分析与止血性能研究. 国际生物医学工程杂志, 2022, (6): 503-507.
8.	Schleckser P. The SURGICEL® powder mild or moderate parenchymal or soft tissue intraoperative bleeding (China study). 2018.
9.	中华人民共和国国务院. 医疗器械监督管理条例. 2021.
10.	国家药品监督管理局. 可吸收再生氧化纤维素止血颗粒获批上市. 2022.
11.	高亚, 刘明, 杨珂璐, 等. 系统评价报告规范: PRISMA 2020与PRISMA 2009的对比分析与实例解读. 中国循证医学杂志, 2021, 21(5): 606-616.
12.	Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ, 2021, 372: n71.
13.	Yang G, Li Z, Li Z, et al. Meta-analysis of the impact of physical activity on the recovery of physical function in COVID-19 patients. Heliyon, 2023, 9(9): e19339.
14.	Bode H, Ivens B, Bschor T, et al. Association of hypothyroidism and clinical depression: a systematic review and meta-analysis. JAMA Psychiatry, 2021, 78(12): 1375-1383.
15.	Krauth D, Woodruff TJ, Bero L. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect, 2013, 121(9): 985-992.
16.	Kunduz E, Aysan E, İdiz UO, et al. Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study. Turk J Surg, 2019, 35(1): 49-53.
17.	NCT. The effect of arista on post-operative bleeding and wound drainage following mastectomy. 2018.
18.	Benjamin T, David AP, Zebolsky AL, et al. Utility of microporous polysaccharide hemosphere on anterolateral thigh free flap donor site complications. Facial Plast Surg Aesthet Med, 2022, 24(4): 295-299.
19.	David AP, Zebolsky AL, Park AM, et al. Effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications. Laryngoscope Investig Otolaryngol, 2022, 7(2): 380-387.
20.	Selfridge JM, Sinner HF, Whiting J, et al. Effect of microporous polysaccharide particles in patients undergoing mastectomy. Clin Breast Cancer, 2022, 22(8): e922-e927.
21.	Gleason S, Mehl D, Payne W, et al. Microporous polysaccharide hemosphere efficacy and safety in primary total knee arthroplasty. J Orthop, 2018, 16(1): 19-24.
22.	Reynbakh O, Akhrass P, Souvaliotis N, et al. Use of MPH hemostatic powder for electrophysiology device implantation reduces postoperative rates of pocket hematoma and infection. Curr Med Res Opin, 2018, 34(10): 1861-1867.
23.	刘天盛, 王琪, 王昊, 等. 复合微孔多聚糖可减少髋关节置换中的出血. 中国组织工程研究, 2015, 19(12): 1872-1877.
24.	Bruckner BA, Blau LN, Rodriguez L, et al. Microporous polysaccharide hemosphere absorbable hemostat use in cardiothoracic surgical procedures. J Cardiothorac Surg, 2014, 9: 134.
25.	Nunez-Nateras R, Hurd KJ, Ferrigni EN, et al. Athermal nerve sparing robot-assisted radical prostatectomy: initial experience with microporous polysaccharide hemospheres as a topical hemostatic agent. World J Urol, 2013, 31(3): 523-527.
26.	Byun Y, Kim EJ, Lee A, et al. In vivo study for the hemostatic efficacy and foreign body reaction of a new powder-type polysaccharide hemostatic agent. Ann Surg Treat Res, 2022, 102(2): 65-72.
27.	MacDonald MH, Tasse L, Wang D, et al. Evaluation of the hemostatic efficacy of two powdered topical absorbable hemostats using a porcine liver abrasion model of mild to moderate bleeding. J Invest Surg, 2021, 34(11): 1198-1206.
28.	Xi C, Zhu L, Zhuang Y, et al. Experimental evaluation of tranexamic acid-loaded porous starch as a hemostatic powder. Clin Appl Thromb Hemost, 2018, 24(2): 279-286.
29.	MacDonald MH, Wang AY, Clymer JW, et al. An in vivo comparison of the efficacy of hemostatic powders, using two porcine bleeding models. Med Devices (Auckl), 2017, 10: 273-279.
30.	Bagcioglu M, Huri E, Dadali M, et al. Comparison of herbal-based and synthetic hemostatic agents for efficacy on a rat partial nephrectomy model: Experimental study. Saudi Med J, 2014, 35(1): 33-38.
31.	Björses K, Holst J. Topical haemostatics in renal trauma--an evaluation of four different substances in an experimental setting. J Trauma, 2009, 66(3): 602-611.
32.	Ereth MH, Schaff M, Ericson EF, et al. Comparative safety and efficacy of topical hemostatic agents in a rat neurosurgical model. Neurosurgery, 2008, 63(4 Suppl 2): 369-372.
33.	Björses K, Holst J. Various local hemostatic agents with different modes of action; an in vivo comparative randomized vascular surgical experimental study. Eur J Vasc Endovasc Surg, 2007, 33(3): 363-370.
34.	Murat FJ, Ereth MH, Dong Y, et al. Evaluation of microporous polysaccharide hemospheres as a novel hemostatic agent in open partial nephrectomy: favorable experimental results in the porcine model. J Urol, 2004, 172(3): 1119-1122.
35.	Tarkova AR, Chernyavskiy AM, Grigor'ev IA, et al. Efficacy of different forms of local hemostatic materials based on oxidize cellulose in the experiment. Vestn Khir Im I I Grek, 2015, 174(6): 56-59.
36.	Allotey JK, King AH, Kumins NH, et al. Systematic review of hemostatic agents used in vascular surgery. J Vasc Surg, 2021, 73(6): 2189-2197.
37.	Shao H, Wu X, Xiao Y, et al. Recent research advances on polysaccharide-, peptide-, and protein-based hemostatic materials: a review. Int J Biol Macromol, 2024, 261(Pt 1): 129752.
38.	Wolny Y, Tam T. Review of hemostatic agents used in robotic assisted laparoscopic gynecological surgeries. J Minim Invasive Gynecol, 2012, 19(6 Suppl 1): S167-S168.
39.	Wang AY, Rafalko J, MacDonald M, et al. Absorbable hemostatic aggregates. ACS Biomater Sci Eng, 2017, 3(12): 3675-3686.
40.	周俭, 孙惠川, 张万广, 等. 肝脏外科手术止血中国专家共识(2023版). 中国实用外科杂志, 2023, 43(1): 48-58.

1. Montazerian H, Davoodi E, Baidya A, et al. Engineered hemostatic biomaterials for sealing wounds. Chem Rev, 2022, 122(15): 12864-12903.
2. Bloom JA, Foroutanjazi S, Erlichman Z, et al. The use of hemostatic agents to decrease bleeding complications in breast cancer surgery. Am Surg, 2023, 89(3): 395-400.
3. Gómez-Ramírez S, Bisbe E, Shander A, et al. Management of perioperative iron deficiency anemia. Acta Haematol, 2019, 142(1): 21-29.
4. Falcone V, Krotka P, Deutschmann C, et al. Use of polysaccharide hemostatic agent (HaemoCer™) in breast cancer surgery to reduce postoperative complications: a randomised controlled trial. Int Wound J, 2023, 20(4): 925-934.
5. Matonick JP, Hammond J. Hemostatic efficacy of EVARREST™, Fibrin Sealant Patch vs. TachoSil® in a heparinized swine spleen incision model. J Invest Surg, 2014, 27(6): 360-365.
6. 冯靖祎, 黄进, 吴航. 医疗机构止血材料管理专家共识. 中国医院建筑与装备, 2021, 22(7): 19-28.
7. 舍浪浪, 毛琳, 宋成利. 外科止血粉的微观结构分析与止血性能研究. 国际生物医学工程杂志, 2022, (6): 503-507.
8. Schleckser P. The SURGICEL® powder mild or moderate parenchymal or soft tissue intraoperative bleeding (China study). 2018.
9. 中华人民共和国国务院. 医疗器械监督管理条例. 2021.
10. 国家药品监督管理局. 可吸收再生氧化纤维素止血颗粒获批上市. 2022.
11. 高亚, 刘明, 杨珂璐, 等. 系统评价报告规范: PRISMA 2020与PRISMA 2009的对比分析与实例解读. 中国循证医学杂志, 2021, 21(5): 606-616.
12. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ, 2021, 372: n71.
13. Yang G, Li Z, Li Z, et al. Meta-analysis of the impact of physical activity on the recovery of physical function in COVID-19 patients. Heliyon, 2023, 9(9): e19339.
14. Bode H, Ivens B, Bschor T, et al. Association of hypothyroidism and clinical depression: a systematic review and meta-analysis. JAMA Psychiatry, 2021, 78(12): 1375-1383.
15. Krauth D, Woodruff TJ, Bero L. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect, 2013, 121(9): 985-992.
16. Kunduz E, Aysan E, İdiz UO, et al. Evaluation of local hemostatic effect of microporous polysaccharide hemospheres products in thyroid surgery: a prospective randomized controlled study. Turk J Surg, 2019, 35(1): 49-53.
17. NCT. The effect of arista on post-operative bleeding and wound drainage following mastectomy. 2018.
18. Benjamin T, David AP, Zebolsky AL, et al. Utility of microporous polysaccharide hemosphere on anterolateral thigh free flap donor site complications. Facial Plast Surg Aesthet Med, 2022, 24(4): 295-299.
19. David AP, Zebolsky AL, Park AM, et al. Effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications. Laryngoscope Investig Otolaryngol, 2022, 7(2): 380-387.
20. Selfridge JM, Sinner HF, Whiting J, et al. Effect of microporous polysaccharide particles in patients undergoing mastectomy. Clin Breast Cancer, 2022, 22(8): e922-e927.
21. Gleason S, Mehl D, Payne W, et al. Microporous polysaccharide hemosphere efficacy and safety in primary total knee arthroplasty. J Orthop, 2018, 16(1): 19-24.
22. Reynbakh O, Akhrass P, Souvaliotis N, et al. Use of MPH hemostatic powder for electrophysiology device implantation reduces postoperative rates of pocket hematoma and infection. Curr Med Res Opin, 2018, 34(10): 1861-1867.
23. 刘天盛, 王琪, 王昊, 等. 复合微孔多聚糖可减少髋关节置换中的出血. 中国组织工程研究, 2015, 19(12): 1872-1877.
24. Bruckner BA, Blau LN, Rodriguez L, et al. Microporous polysaccharide hemosphere absorbable hemostat use in cardiothoracic surgical procedures. J Cardiothorac Surg, 2014, 9: 134.
25. Nunez-Nateras R, Hurd KJ, Ferrigni EN, et al. Athermal nerve sparing robot-assisted radical prostatectomy: initial experience with microporous polysaccharide hemospheres as a topical hemostatic agent. World J Urol, 2013, 31(3): 523-527.
26. Byun Y, Kim EJ, Lee A, et al. In vivo study for the hemostatic efficacy and foreign body reaction of a new powder-type polysaccharide hemostatic agent. Ann Surg Treat Res, 2022, 102(2): 65-72.
27. MacDonald MH, Tasse L, Wang D, et al. Evaluation of the hemostatic efficacy of two powdered topical absorbable hemostats using a porcine liver abrasion model of mild to moderate bleeding. J Invest Surg, 2021, 34(11): 1198-1206.
28. Xi C, Zhu L, Zhuang Y, et al. Experimental evaluation of tranexamic acid-loaded porous starch as a hemostatic powder. Clin Appl Thromb Hemost, 2018, 24(2): 279-286.
29. MacDonald MH, Wang AY, Clymer JW, et al. An in vivo comparison of the efficacy of hemostatic powders, using two porcine bleeding models. Med Devices (Auckl), 2017, 10: 273-279.
30. Bagcioglu M, Huri E, Dadali M, et al. Comparison of herbal-based and synthetic hemostatic agents for efficacy on a rat partial nephrectomy model: Experimental study. Saudi Med J, 2014, 35(1): 33-38.
31. Björses K, Holst J. Topical haemostatics in renal trauma--an evaluation of four different substances in an experimental setting. J Trauma, 2009, 66(3): 602-611.
32. Ereth MH, Schaff M, Ericson EF, et al. Comparative safety and efficacy of topical hemostatic agents in a rat neurosurgical model. Neurosurgery, 2008, 63(4 Suppl 2): 369-372.
33. Björses K, Holst J. Various local hemostatic agents with different modes of action; an in vivo comparative randomized vascular surgical experimental study. Eur J Vasc Endovasc Surg, 2007, 33(3): 363-370.
34. Murat FJ, Ereth MH, Dong Y, et al. Evaluation of microporous polysaccharide hemospheres as a novel hemostatic agent in open partial nephrectomy: favorable experimental results in the porcine model. J Urol, 2004, 172(3): 1119-1122.
35. Tarkova AR, Chernyavskiy AM, Grigor'ev IA, et al. Efficacy of different forms of local hemostatic materials based on oxidize cellulose in the experiment. Vestn Khir Im I I Grek, 2015, 174(6): 56-59.
36. Allotey JK, King AH, Kumins NH, et al. Systematic review of hemostatic agents used in vascular surgery. J Vasc Surg, 2021, 73(6): 2189-2197.
37. Shao H, Wu X, Xiao Y, et al. Recent research advances on polysaccharide-, peptide-, and protein-based hemostatic materials: a review. Int J Biol Macromol, 2024, 261(Pt 1): 129752.
38. Wolny Y, Tam T. Review of hemostatic agents used in robotic assisted laparoscopic gynecological surgeries. J Minim Invasive Gynecol, 2012, 19(6 Suppl 1): S167-S168.
39. Wang AY, Rafalko J, MacDonald M, et al. Absorbable hemostatic aggregates. ACS Biomater Sci Eng, 2017, 3(12): 3675-3686.
40. 周俭, 孙惠川, 张万广, 等. 肝脏外科手术止血中国专家共识(2023版). 中国实用外科杂志, 2023, 43(1): 48-58.

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