A Single-Center Open-Label Single-Arm Study Evaluating Efficacy and Safety of Skin Adhesive Epinexus<sup>TM</sup>in Surgical Patients

• 作者: Aki Honda Hiromitsu Jinno Kazuo Kishi Keisuke Okabe Maiko Takahashi Masataka Saito Noriko Aramaki-Hattori Takeya Adachi Tetsu Hayashida Yoshiaki Sakamoto Yuko Kitagawa
• 来源期刊: 现代整形外科(英文)
• 学科: 医学
• 关键词: COSMETIC Techniques Clinical STUDY WOUNDS and Injury
• 年，卷（期）: 2017,（4）
• 页码范围: 31-38
• 页数: 8页
• 分类号: R73

摘要

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.