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Comparison of Efficacy and Safety of Non-Regenerated and Regenerated Oxidized Cellulose Based Fibrous Haemostats
Petr Habal1, Veronika Sívková2, Petr Votava3
1Department of Cardiac Surgery, Charles University, Faculty of Medicine and University Hospital in Hradec Králové, Czech Republic.
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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