Comparison of sfilm-FS and TACHOSIL in patients undergoing liver surgical procedures requiring hemostasis – A phase 1/2, randomised, controlled study

IF 2.7 3区医学 Q1 SURGERY

American journal of surgery Pub Date : 2025-07-28 DOI:10.1016/j.amjsurg.2025.116543

Grant Bochicchio , Helwig Wundsam , Blaž Trotovšek , Jack Spira , Eran Cohen , Sara Horn , Luca Maravigna , Massimo Iacobelli , Elisabetta Musazzi , Guido Fedele , Yuri Genyk , Christopher C. Lamb , Luigi Marano , Orgad Laub

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引用次数: 0

Abstract

This Phase I/II randomized, controlled, multicenter study aimed to evaluate the safety and efficacy of sFilm-FS compared to Tachosil® in patients undergoing elective liver surgery requiring hemostasis at the liver surface. sFilm-FS is a new fibrin sealant patch, coating on a biodegradable tri-block polymeric film.

The trial included 33 patients randomized 1:1 to receive sFilm-FS or Tachosil®. While most patients underwent liver resection, a subset underwent other hepatic surgical interventions.

Safety was the primary outcome, including treatment-emergent adverse events, coagulopathies, and intraoperative blood loss. Efficacy was assessed as secondary endpoints by the time to hemostasis and hemostasis at 2, 3, 5, 7, and 10 min from product application. Hemostasis was defined as the absence of bleeding at the target bleeding site within 10 min.

Both treatments were well tolerated, with no significant differences in adverse events. All patients achieved hemostasis within 10 min. The median time to hemostasis was 2 min for sFilm-FS and 3 min for Tachosil®.

sFilm-FS is a promising, well tolerated, fibrin sealant patch, offering the potential for a superior Fibrin Sealant patch that could improve surgical outcomes. Further studies are recommended to validate these findings in larger populations.

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sfilm-FS和TACHOSIL在需要止血的肝脏手术患者中的比较——1/2期随机对照研究

这项I/II期随机、对照、多中心研究旨在评估sFilm-FS与Tachosil®在需要肝表面止血的择期肝脏手术患者中的安全性和有效性。sFilm-FS是一种新型的纤维蛋白密封贴剂，涂覆在可生物降解的三嵌段聚合物薄膜上。该试验包括33名患者，以1:1的比例随机分配接受sFilm-FS或Tachosil®治疗。虽然大多数患者接受了肝切除术，但有一部分患者接受了其他肝脏手术干预。安全性是主要结局，包括治疗后出现的不良事件、凝血功能障碍和术中失血。通过止血时间和产品应用后2、3、5、7和10分钟的止血来评估疗效作为次要终点。止血定义为靶出血部位在10分钟内无出血。两种治疗均耐受良好，不良事件无显著差异。所有患者均在10分钟内止血。sFilm-FS的中位止血时间为2分钟，而Tachosil®的中位止血时间为3分钟。sFilm-FS是一种很有前途的、耐受性良好的纤维蛋白密封胶贴片，提供了一种更好的纤维蛋白密封胶贴片的潜力，可以改善手术结果。建议进一步研究以在更大的人群中验证这些发现。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American journal of surgery 医学-外科

CiteScore

5.00

自引率

6.70%

发文量

570

审稿时长

56 days

期刊介绍： The American Journal of Surgery® is a peer-reviewed journal designed for the general surgeon who performs abdominal, cancer, vascular, head and neck, breast, colorectal, and other forms of surgery. AJS is the official journal of 7 major surgical societies* and publishes their official papers as well as independently submitted clinical studies, editorials, reviews, brief reports, correspondence and book reviews.