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

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11150%2F22%3A10451087" target="_blank" >RIV/00216208:11150/22:10451087 - isvavai.cz</a>
Alternative codes found
RIV/00179906:_____/22:10451087
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=LeHzb7rbH" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=LeHzb7rbH</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.14712/18059694.2022.18" target="_blank" >10.14712/18059694.2022.18</a>

Result language
angličtina
Original language name
Comparison of Efficacy and Safety of Non-Regenerated and Regenerated Oxidized Cellulose Based Fibrous Haemostats
Original language description
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.
Czech name
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Czech description
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Type
J<sub>SC</sub> - Article in a specialist periodical, which is included in the SCOPUS database
CEP classification
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OECD FORD branch
30212 - Surgery

Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2022
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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