Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský
{"title":"氧化纤维素粉及内镜下涂抹器在多中心试验中的临床评价。","authors":"Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský","doi":"10.14712/18059694.2025.13","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":101400,"journal":{"name":"Acta medica (Hradec Kralove)","volume":"68 1","pages":"14-20"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial.\",\"authors\":\"Petr Habal, Veronika Sívková, Zdeněk Šorm, Milan Chobola, Jiří Feix, Igor Slaninka, Jiřina Habalová, Tomáš Hosszú, Jaroslav Pacovský\",\"doi\":\"10.14712/18059694.2025.13\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":101400,\"journal\":{\"name\":\"Acta medica (Hradec Kralove)\",\"volume\":\"68 1\",\"pages\":\"14-20\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta medica (Hradec Kralove)\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14712/18059694.2025.13\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta medica (Hradec Kralove)","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14712/18059694.2025.13","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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 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.