TITLE:
A Single-Center Open-Label Single-Arm Study Evaluating Efficacy and Safety of Skin Adhesive EpinexusTM in Surgical Patients
AUTHORS:
Kazuo Kishi, Noriko Aramaki-Hattori, Yoshiaki Sakamoto, Keisuke Okabe, Tetsu Hayashida, Maiko Takahashi, Yuko Kitagawa, Masataka Saito, Takeya Adachi, Aki Honda, Hiromitsu Jinno
KEYWORDS:
Cosmetic Techniques, Clinical Study, Wounds and Injury
JOURNAL NAME:
Modern Plastic Surgery,
Vol.7 No.4,
August
17,
2017
ABSTRACT: Existing skin adhesives may, however, cause inflammatory response to
toxicity of formaldehyde generated as hydrolysate of polycyanoacrylate (the main
ingredient), delay in wound closure due to the adhesive’s flowing into the
wound from the edges, or a wide scar. EpinexusTM (Mitsui Chemicals, Inc.), the
skin adhesive used for this study, was developed to prevent these risks. For
the method of this study, This was a single-center, open-label, single-arm,
intervention study of an acrylate skin adhesive, EpinexusTM. The primary
endpoint was safety. The secondary endpoints were wound closure, cosmetic
outcome (Manchester Scar Scale), and usability. Failures and adverse events
were also appropriately evaluated. As a result, there were no particular
adverse events such as inflammatory findings, which demonstrated that there is
no problem in safety. Some common adverse events were observed, but no adverse
events for which a causal relationship cannot be ruled out or failures. As a
conclusion, there was no problem in wound closure, cosmetic outcome, or
usability. This was a pilot study of EpinexusTM of an ongoing, single-center,
open-label, parallel-group, comparative study in 60 subjects comparing EpinexusTMwith an existing skin adhesive, Dermabond? Advanced.