Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10498802" target="_blank" >RIV/00179906:_____/25:10498802 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11150/25:10498802

Výsledek na webu

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=~okMp0uVoc" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=~okMp0uVoc</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.14712/18059694.2025.13" target="_blank" >10.14712/18059694.2025.13</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial

Popis výsledku v původním jazyce

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 &lt; 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.

Název v anglickém jazyce

Clinical Evaluation of Oxidized Cellulose Powder and Endoscopic Applicator in Multicenter Trial

Popis výsledku anglicky

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 &lt; 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.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

30212 - Surgery

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Acta Medica (Hradec Králové)

ISSN

1211-4286

e-ISSN

1805-9694

Svazek periodika

68

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

7

Strana od-do

14-20

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-105008721216