Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial
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 prospect...
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| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Karolinum Press
2025-06-01
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| Series: | Acta Medica |
| Online Access: | https://actamedica.lfhk.cuni.cz/68/1/0014/ |
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| Summary: | 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. |
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| ISSN: | 1211-4286 1805-9694 |