OBJECTIVE: To assess the safety and performance of a new energy-based skin closure system (BioWeld1(TM)) for the surgical Pfannenstiel incision in patients scheduled for elective cesarean section. METHODS: This prospective, single center, non-randomized study included 20 patients who were scheduled for elective cesarean section. The BioWeld1 system was performed after suturing the internal layers of the cesarean section incision. A clinical evaluation of safety and efficacy was performed for 1, 2, 4-7, 21, and 45 d after the procedure. The Vancouver Scar Scale (VSS) was used to evaluate scarring. RESULTS: Up to 21 d after the procedure, no safety device-related adverse events were reported. All patients had full closure of the epidermis, a very low total VSS score, and no evidence of discharge, redness, edema, or thermal damage. None of the patients exhibited more than a mild degree of encrustation. CONCLUSION: The BioWeld1 System has been shown to be safe and effective for skin closure in cesarean section.
J Matern Fetal Neonatal Med
1637 - 1642
Chitosan, cold helium plasma, skin closure, Adult, Cesarean Section, Chitosan, Female, Helium, Humans, Plasma Gases, Pregnancy, Prospective Studies, Suture Techniques, Treatment Outcome, Young Adult