Hemostatic effect of oxidized regenerated cellulose vs. topical tranexamic acid in total knee arthroplasty-a prospective randomized controlled trial.

IF 1.6 4区医学 Q2 SURGERY Frontiers in Surgery Pub Date : 2025-01-07 eCollection Date: 2024-01-01 DOI:10.3389/fsurg.2024.1515610

Bowei Li, Wenjie Pan, Jianbing Ma, Yuanchi Huang

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Abstract

Aims: This study compared the hemostatic effects and complications of oxidized regenerated cellulose (ORC) and topical TXA in total knee arthroplasty (TKA), thus providing a reference for the use of ORC as an alternative hemostatic agent to TXA in TKA.

Methods: A total of 105 patients were included in this study and randomized into blank control, ORC, and TXA groups. The primary outcomes were total blood loss, hemoglobin drop (Hb drop), transfusion rates, and incidence of thrombosis. The secondary outcomes included operation time, tourniquet duration, coagulation parameters, inflammation markers, and complication rates.

Results: Total blood loss was 1,002.47 ± 308.58 ml and 964.68 ± 273.00 ml in the ORC and TXA groups, respectively, both significantly lower than that in the blank control group (1,168.94 ± 405.04 ml) (P ₁ = 0.043 and P ₂ = 0.014, respectively). Hb Drop was statistically insignificantly different between the ORC (36.03 ± 12.17 g/L) and TXA (34.32 ± 10.19 g/L) groups (P = 0.555). There was no statistically significant difference in transfusion rate, operation time, tourniquet duration, coagulation parameters, inflammation markers, and complication rates among the three groups.

Conclusion: In conclusion, our prospective randomized controlled trial (RCT) highlights that, oxidized regenerated cellulose (ORC) can reduce postoperative invisible blood loss in total knee arthroplasty and achieve a hemostatic effect similar to topical tranexamic acid (TXA). This provides a safe and effective hemostatic option for patients with severe underlying diseases or contraindications to tranexamic acid.

Clinical trial registration: https://www.chictr.org.cn/bin/project/edit?pid=186370, identifier (ChiCTR2200066633).

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氧化再生纤维素与局部氨甲环酸在全膝关节置换术中的止血效果——一项前瞻性随机对照试验。

目的：本研究比较氧化再生纤维素（ORC）与外用TXA在全膝关节置换术（TKA）中的止血效果及并发症，为在TKA中使用ORC作为TXA的替代止血剂提供参考。方法：本研究共纳入105例患者，随机分为空白对照组、ORC组和TXA组。主要结局是总失血量、血红蛋白下降（Hb下降）、输血率和血栓发生率。次要结果包括手术时间、止血带持续时间、凝血参数、炎症指标和并发症发生率。结果：ORC组和TXA组总失血量分别为1002.47±308.58 ml和964.68±273.00 ml，均显著低于空白对照组（1168.94±405.04 ml）（P < 0.01）和P < 0.05 （P < 0.01）。ORC组Hb Drop（36.03±12.17 g/L）与TXA组Hb Drop（34.32±10.19 g/L）差异无统计学意义（P = 0.555）。三组患者输血率、手术时间、止血带时间、凝血指标、炎症指标、并发症发生率比较，差异均无统计学意义。结论：本前瞻性随机对照试验（RCT）强调，氧化再生纤维素（ORC）可减少全膝关节置换术术后隐性失血量，达到与外用氨甲环酸（TXA）相似的止血效果。这为有严重基础疾病或氨甲环酸禁忌症的患者提供了一种安全有效的止血选择。临床试验注册：https://www.chictr.org.cn/bin/project/edit?pid=186370，标识符（ChiCTR2200066633）。

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来源期刊

Frontiers in Surgery Medicine-Surgery

CiteScore

1.90

自引率

11.10%

发文量

1872

审稿时长

12 weeks

期刊介绍： Evidence of surgical interventions go back to prehistoric times. Since then, the field of surgery has developed into a complex array of specialties and procedures, particularly with the advent of microsurgery, lasers and minimally invasive techniques. The advanced skills now required from surgeons has led to ever increasing specialization, though these still share important fundamental principles. Frontiers in Surgery is the umbrella journal representing the publication interests of all surgical specialties. It is divided into several “Specialty Sections” listed below. All these sections have their own Specialty Chief Editor, Editorial Board and homepage, but all articles carry the citation Frontiers in Surgery. Frontiers in Surgery calls upon medical professionals and scientists from all surgical specialties to publish their experimental and clinical studies in this journal. By assembling all surgical specialties, which nonetheless retain their independence, under the common umbrella of Frontiers in Surgery, a powerful publication venue is created. Since there is often overlap and common ground between the different surgical specialties, assembly of all surgical disciplines into a single journal will foster a collaborative dialogue amongst the surgical community. This means that publications, which are also of interest to other surgical specialties, will reach a wider audience and have greater impact. The aim of this multidisciplinary journal is to create a discussion and knowledge platform of advances and research findings in surgical practice today to continuously improve clinical management of patients and foster innovation in this field.