title: 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: BACKGROUND
  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
  
  
  METHODS
  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
  
  
  RESULTS
  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
  
  
  CONCLUSIONS
  The tested topical cyanoacrylate had a positive effect on the scar maturation process at least comparable with that of topical silicone gel.
authors.affiliation: Department of Plastic and Reconstructive Surgery, La Sapienza University of Rome, Viale del Policlinico 155, Rome, Italy.
authors.forename: Nicolò
authors.initials: N
authors.lastname: Scuderi
authors.forename: Luca A
authors.initials: LA
authors.lastname: Dessy
authors.forename: Ernesto M
authors.initials: EM
authors.lastname: Buccheri
authors.forename: Francesco
authors.initials: F
authors.lastname: Marchetti
authors.forename: Marco
authors.initials: M
authors.lastname: Mazzocchi
authors.forename: Stefano
authors.initials: S
authors.lastname: Chiummariello
authors.forename: Francesco
authors.initials: F
authors.lastname: Klinger
authors.forename: Maria G
authors.initials: MG
authors.lastname: Onesti
authors.forename: Marco
authors.initials: M
authors.lastname: Klinger
authors.forename: Carmine
authors.initials: C
authors.lastname: Alfano
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D002921:Cicatrix / Q000209:etiology / Q000517:prevention & control*; D018592:Cross-Over Studies; D003487:Cyanoacrylates / Q000008:administration & dosage*; D005782:Gels; D006801:Humans; D016462:Mammaplasty / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D020034:Silicone Gels / Q000008:administration & dosage*; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D003487:Cyanoacrylates; D005782:Gels; D020034:Silicone Gels