Preliminary evaluation of novel skin closure of Pfannenstiel incisions using cold helium plasma and chitosan films.
Hants Y., Kabiri D., Drukker L., Razmik A., Vruyr G., Arusyak H., Vahe G., Di Renzo GC., Ezra Y.
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.