This single-center, randomized, and controlled intervention study compared an acrylate skin adhesive, EpinexusTM (Mitsui Chemicals, Inc., Tokyo) with Dermabond AdvancedR (Ethicon, Inc., Somerville, New Jersey). The pr...This single-center, randomized, and controlled intervention study compared an acrylate skin adhesive, EpinexusTM (Mitsui Chemicals, Inc., Tokyo) with Dermabond AdvancedR (Ethicon, Inc., Somerville, New Jersey). The primary endpoint was cosmetic outcome at 52 weeks after treatment (Manchester Scar Scale), and the secondary endpoints were cosmetic outcome at 4 and 26 weeks after treatment (Manchester Scar Scale), wound closure, and usability. We evaluated 59 patients (29 cases and 30 controls). Failures and adverse events were also evaluated, and 8 adverse events (5 cases and 3 controls) were reported (epidermolysis, n = 4;contact dermatitis, n = 1;eczema, n = 1;and surgical wound dehiscence, n = 2). No difference was observed between groups in cosmetic outcome at 52 and 24 weeks;however, at 4 weeks, cases showed better cosmetic outcome compared with controls. With regard to usability, the treatment duration and application time were significantly longer with EpinexusTM, and ease of application was significantly better with Dermabond AdvancedR.展开更多
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 ...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.展开更多
文摘This single-center, randomized, and controlled intervention study compared an acrylate skin adhesive, EpinexusTM (Mitsui Chemicals, Inc., Tokyo) with Dermabond AdvancedR (Ethicon, Inc., Somerville, New Jersey). The primary endpoint was cosmetic outcome at 52 weeks after treatment (Manchester Scar Scale), and the secondary endpoints were cosmetic outcome at 4 and 26 weeks after treatment (Manchester Scar Scale), wound closure, and usability. We evaluated 59 patients (29 cases and 30 controls). Failures and adverse events were also evaluated, and 8 adverse events (5 cases and 3 controls) were reported (epidermolysis, n = 4;contact dermatitis, n = 1;eczema, n = 1;and surgical wound dehiscence, n = 2). No difference was observed between groups in cosmetic outcome at 52 and 24 weeks;however, at 4 weeks, cases showed better cosmetic outcome compared with controls. With regard to usability, the treatment duration and application time were significantly longer with EpinexusTM, and ease of application was significantly better with Dermabond AdvancedR.
文摘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.
