Kazuo Kishi^1*, Noriko Aramaki-Hattori¹, Yoshiaki Sakamoto¹, Keisuke Okabe¹, Tetsu Hayashida², Maiko Takahashi², Yuko Kitagawa², Masataka Saito³, Takeya Adachi³, Aki Honda³, Hiromitsu Jinno⁴

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¹ Department of Plastic and Reconstructive Surgery, Keio University School of Medicine, Tokyo, Japan.
² Department of Surgery, Keio University School of Medicine, Tokyo, Japan.
³ Department of Dermatology, Keio University School of Medicine, Tokyo, Japan.
⁴ Department of Surgery, Teikyo University School of Medicine, Tokyo, Japan.
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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. Epinexus^TM (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, Epinexus^TM. 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 Epinexus^TM of an ongoing, single-center, open-label, parallel-group, comparative study in 60 subjects comparing Epinexus^TMwith an existing skin adhesive, Dermabond? Advanced.

Keywords: Cosmetic Techniques, Clinical Study, Wounds and Injury

Cite this paper: Kishi, K. , Aramaki-Hattori, N. , Sakamoto, Y. , Okabe, K. , Hayashida, T. , Takahashi, M. , Kitagawa, Y. , Saito, M. , Adachi, T. , Honda, A. and Jinno, H. (2017) A Single-Center Open-Label Single-Arm Study Evaluating Efficacy and Safety of Skin Adhesive Epinexus^TM in Surgical Patients. Modern Plastic Surgery, 7, 31-38. doi: 10.4236/mps.2017.74004.

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