Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study

Young-Mok Park; Hyung-Il Seo; Jae-Hoon Kim; Sung Pil Yoon; Haeshin Lee; Moon Sue Lee

doi:10.14701/ahbps.21-077

Clinical application of a new hemostatic material using mussel-inspired catecholamine hemostat: A pilot study

Ann Hepatobiliary Pancreat Surg. 2022 Feb 28;26(1):98-103. doi: 10.14701/ahbps.21-077.

Authors

Young-Mok Park¹, Hyung-Il Seo¹, Jae-Hoon Kim², Sung Pil Yoon³, Haeshin Lee⁴, Moon Sue Lee⁵

Affiliations

¹ Department of Surgery, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.
² Department of Trauma Surgery and Surgical Critical Care, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea.
³ Department of Surgery, Gang-an Hospital, Busan, Korea.
⁴ Department of Chemistry, Korea Advanced Institute of Science and Technology (KAIST), Daejeon, Korea.
⁵ InnoTherapy Inc., Seoul, Korea.

Abstract

Backgrounds/aims: This study aimed to evaluate clinical application of InnoSEAL Plus (a mussel-inspired catecholamine hemostat) as a new hemostatic material for humans.

Methods: 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.

Results: 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 (p > 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.

Conclusions: 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.

Keywords: Hemostatics; Hepatectomy; Mussel adhesion; Pilot study.