Comparison of mastectomy and breast reconstruction outcomes using low thermal dissection versus traditional electrocautery: a blinded randomized trial.

INTRODUCTION

PlasmaBlade® is a thermal dissection device that may allow for improved perfusion of the mastectomy flap by limiting thermal injury. In this study we aim to compare the mastectomy flap perfusion using PlasmaBlade® versus traditional electrocautery.

METHODS

Patients undergoing bilateral mastectomy with immediate breast reconstruction were recruited. The right and left breasts of each patient were randomized to dissection with PlasmaBlade® or standard electrocautery. Randomization was performed using random sequences on the day of surgery and was blinded to the plastic surgeon. Mastectomy flap perfusion was assessed following completion of the mastectomy using intra-operative fluoroscopy and plastic surgeon review. Surgical site drainage and pain score were measured. Sign tests were employed to assess differences in perfusion and Wilcoxon paired test for the secondary outcomes.

RESULTS

Twenty patients were enrolled in the study with median age of 40.5 years and median BMI of 26 kg/m. In 18 patients (90%), perfusion was assessed to be better on the side of the PlasmaBlade® dissection. Median daily drainage over a 7-day period was 51 cc (IQR 35-61) on the PlasmaBlade® side and 44 cc (IQR 31-61) on the control side. Median pain score on the PlasmaBlade® side was 4.0 (IQR 2.3-5.9) and 4.4 (IQR 2.9-6) on the control side. No skin necrosis was noted in either groups.

CONCLUSION

Use of PlasmaBlade® appears to be a safe and reliable technique to perform mastectomy and breast reconstruction with equivalent outcomes to traditional electrocautery. Although, mastectomy skin flap perfusion was rated better intra-operatively for the PlasmaBlade® group, both cohorts had comparable outcomes. ClinicalTrials.gov Identifier: NCT03711916 Level of Evidence: I (Randomized trial).