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Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial
Petr Habal1, Veronika Sívková2, Zdeněk Šorm1
1Department of Cardiac Surgery, Charles University, Faculty of Medicine and University Hospital in Hradec Králové, Czech Republic.
Purpose:
Oxidized cellulose-based haemostatic agents are widely used for managing bleeding in various surgical procedures. This study evaluates the efficacy and safety of oxidized cellulose powder and an endoscopic applicator across a broad spectrum of surgical settings.
Methods:
This was a prospective, multicentre study involving 99 evaluable patients undergoing surgeries with varying bleeding severities and surgical approaches (open, laparoscopic, or thoracoscopic). The primary endpoint was achieving haemostasis within 3 minutes and avoiding revision surgery within 12 hours. The time to haemostasis (TTH) and complications were recorded, and statistical comparisons were made using a paired and unpaired t-test, with a significance threshold of P < 0.05. Data from this study were compared to historical results from fibrillar haemostats.
Results:
Haemostasis was achieved within 3 minutes in 61.6% (95% CI [52.0, 71.2]) of patients and within 5 minutes in 99.0% (95% CI [97.0, 100.0]) of patients. The overall mean TTH was 153.8 seconds (95% CI: 141.5-166.1), with shorter TTH observed in minimally invasive procedures using the endoscopic applicator. Subgroup analysis revealed higher success rates for patients with mild bleeding (78%) compared to moderate bleeding (50%).
Conclusion:
Oxidized cellulose powder demonstrates reliable haemostatic performance across diverse surgical applications. The endoscopic applicator enhances precision and applicability, particularly in minimally invasive settings, making it a valuable tool in modern surgical practice.
