Division of General and Transplant Surgery, University of Pisa, Pisa, Italy.
Hepatobiliary and Pancreatic Surgery Unit, Hospital Universitari de Girona Doctor Josep Trueta, Girona, Spain.
Updates Surg. 2022 Oct;74(5):1521-1531. doi: 10.1007/s13304-022-01353-y. Epub 2022 Aug 20.
Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch registry shows that Hemopatch efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.
手术过程常常会受到出血和/或体液泄漏的阻碍。这些并发症并不总是可以通过传统的手术技术来解决。Hemopatch 是一种止血贴，同时也具有密封剂的功能。在这里，我们记录了 Hemopatch 在多个外科专业常规手术中的有效性和安全性。为此，我们进行了一项前瞻性、多中心、单臂、观察性注册研究。如果患者在这些专业中的任何一个专业的开放或微创手术中接受了 Hemopatch，则有资格入组：肝胆、心血管、泌尿科、神经/脊柱、普外科或肺部手术。如果患者对牛蛋白或亮蓝有已知的过敏反应、术中搏动性或严重出血和/或目标应用部位（TAS）有感染，则将被排除在外。术中有效性的主要终点是止血效果，评估标准为在 2 分钟内实现止血的患者比例以及在手术关闭时没有再次出血的患者比例。该注册研究在欧洲六个国家的 23 个研究点共招募了 621 名患者。620 名患者完成了随访信息。在所有 621 个 TAS 中，有 463 个（74.5%）在 2 分钟内实现了止血。在 620 个 TAS 中观察到没有再次出血的止血效果。64 名患者（10.3%）报告了不良事件。这项 Hemopatch 注册研究表明，Hemopatch 在包括微创手术在内的各种外科专业中能够有效地实现止血和密封。此外，我们还提供了该注册研究中包含的所有专业的 Hemopatch 安全性的证据。本研究在 clinicaltrials.gov 上注册：NCT03392662。
