Comparison of Efficacy and Safety of Non-Regenerated and Regenerated Oxidized Cellulose Based Fibrous Haemostats.

Q3 Medicine

Acta medica (Hradec Kralove) Pub Date : 2022-01-01 DOI:10.14712/18059694.2022.18

Petr Habal, Veronika Sívková, Petr Votava

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引用次数: 0

Abstract

Purpose: Various forms of local haemostats are increasingly used routinely in surgical procedures. Our work is the first comparison of the efficacy and safety of non-regenerated and regenerated oxidized cellulose based fibrous haemostats.

Methods: The haemostatic efficacy and safety of fibrous haemostats based on ONRC and ORC were compared in a randomized multicenter study. The primary endpoint was successful haemostasis within 3 minutes of application and no need for surgical revision within 12 hours after the procedure for recurrent bleeding.

Results: There was a significant difference in the rate of successful haemostasis in 3 minutes that was achieved in 82% and 55% in the ONRC and ORC groups, respectively (confidence interval 99%; p = 0.009). Mean time to haemostasis was 133.9 ± 53.95 seconds and 178.0 ± 82.33 seconds, in the ONRC, and ORC group, respectively (p = 0.002). Revision surgery for re-bleeding was necessary in 0 (0%), and 1 (2%) of patients in the ONRC, and ORC group, respectively. No adverse events were reported.

Conclusion: Fibrous haemostat based on ONRC was non-inferior compared to fibrous haemostat based on ORC when used in accordance with its intended purpose, and was safe and efficient.

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非再生和再生氧化纤维素基纤维止血剂的疗效和安全性比较。

目的:各种形式的局部止血药越来越多地用于常规外科手术。我们的工作是第一次比较非再生和再生氧化纤维素纤维止血剂的有效性和安全性。方法:采用随机多中心研究，比较基于ONRC和ORC的纤维止血剂的止血疗效和安全性。主要终点是在应用3分钟内成功止血，并且在手术后12小时内不需要再进行手术翻修。结果:ONRC组和ORC组3分钟内成功止血率分别为82%和55%，差异有统计学意义(置信区间99%;P = 0.009)。ONRC组和ORC组的平均止血时间分别为133.9±53.95秒和178.0±82.33秒(p = 0.002)。在ONRC组和ORC组中，分别有0(0%)和1(2%)的患者需要再出血翻修手术。无不良事件报告。结论:基于ONRC的纤维性止血剂与基于ORC的纤维性止血剂相比，在按照其预期用途使用时并不差，并且安全有效。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Acta medica (Hradec Kralove) Medicine-Medicine (all)

CiteScore

1.10

自引率

0.00%

发文量

审稿时长

20 weeks

期刊介绍： Acta Medica (Hradec Králové) is a multidisciplinary medical journal published by the Faculty of Medicine in Hradec Králové - Karolinum Press, the publishing house of Charles University. The journal is peer-reviewed and published quarterly in both paper and electronic form. The language of Acta Medica is English. Offerings include review articles, original articles, brief communications, case reports, announcements and notices. The journal was founded in 1958 under the title "A Collection of Scientific Works of the Charles University Faculty of Medicine in Hradec Kralove."