Park Young-Mok, Seo Hyung-Il, Kim Jae-Hoon, Yoon Sung Pil, Lee Haeshin, Lee Moon Sue
Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.
Department of Trauma Surgery and Surgical Critical Care, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.
Ann Hepatobiliary Pancreat Surg. 2022 Feb 28;26(1):98-103. doi: 10.14701/ahbps.21-077.
BACKGROUNDS/AIMS: This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans.
Patients treated with topical hemostatic patches after liver resection were enrolled. They were divided into an experimental group (InnoSEAL Plus group) and two control groups (TachoSil group and Surgicel Fibrillar group) for efficacy evaluation.
A total of 15 patients were enrolled. Each group had five patients. The 3-minute hemostasis success rate was 80.0% (4/5 patients) in the InnoSEAL Plus group, 80.0% (4/5 patients) in the TachoSil group, and 40.0% (2/5 patients) in the Surgicel Fibrillar group, showing no significant difference in the success rate among these groups ( > 0.05). All three groups exhibited 100% success rate for 10-minute hemostasis. Both InnoSEAL Plus and TachoSil groups had one patient developing adverse events, which were treated easily with drug administrations.
InnoSEAL Plus is expected to be functionally not inferior to other conventional hemostatic agents. However, it is necessary to confirm this through multicenter prospective studies in the future.
背景/目的:本研究旨在评估InnoSEAL Plus(一种受贻贝启发的儿茶酚胺止血剂)作为一种新型人类止血材料的临床应用。
纳入肝切除术后接受局部止血贴片治疗的患者。将他们分为实验组(InnoSEAL Plus组)和两个对照组(TachoSil组和Surgicel Fibrillar组)进行疗效评估。
共纳入15例患者。每组5例患者。InnoSEAL Plus组3分钟止血成功率为80.0%(4/5例患者),TachoSil组为80.0%(4/5例患者),Surgicel Fibrillar组为40.0%(2/5例患者),这些组之间的成功率无显著差异(>0.05)。所有三组10分钟止血成功率均为100%。InnoSEAL Plus组和TachoSil组各有1例患者发生不良事件,经药物治疗后容易处理。
InnoSEAL Plus预计在功能上不劣于其他传统止血剂。然而,未来有必要通过多中心前瞻性研究来证实这一点。