Objective: To assess the safety and performance of a new energy-based skin closure system (BioWeld1TM) 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 45d after the procedure. The Vancouver Scar Scale (VSS) was used to evaluate scarring. Results: Up to 21d 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.
- Cold helium plasma
- Skin closure