Phase 2 Cross-Over Multicenter Trial on the Efficacy and Safety of Topical Cyanoacrylates Compared with Topical Silicone Gel in the Prevention of Pathologic Scars

Abstract

Many clinical studies on scar therapy are reported in the literature, but only silicone gel sheeting and corticosteroid injections are supported by accurate prospective controlled studies. This prospective multicenter cross-over phase 2 study tested the effectiveness of a topical cyanoacrylate compared with silicone gel in improving postsurgical scars Patients presenting with symmetric breast scars after augmentation or reduction mammaplasty were enrolled in the study. From the same day as stitch removal, the cyanoacrylate was applied on one side every 3 to 5 days and the silicone gel on the other side twice a day for 3 months. Assessments of patients and external observers using a visual analog scale were recorded at scheduled visits during 1 year, and scars were photographed. Objective evaluations included measurements of scar width, length, and elevation. The statistical significance of objective parameter modifications was analyzed using the Wilcoxon test Positive effects of both tested products were observed during the scar maturation process, and final scars of good quality were achieved without any major adverse effect. The topical cyanoacrylate proved to be more efficacious in preventing scar widening, and this result was statistically significant The tested topical cyanoacrylate had a positive effect on the scar maturation process at least comparable with that of topical silicone gel.