Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery

This is a single-blinded, randomized, controlled clinical trial comparing postoperative flap perfusion and surgical site drainage between patients randomized to breast flap creation by PlasmaBlade (low thermal dissection intervention) on one breast and by a Bovie cautery (Control) for the contralateral breast flap. Candidates will have elected to undergo bilateral post-mastectomy immediate breast reconstruction (IBR). Participants meeting inclusion criteria will be enrolled and baseline data collection completed prior to randomization and surgery.

Patients and the plastic surgeon will be blinded in regards to intervention randomization. Only the oncology surgeon has knowledge of which device used for each breast flap. However, after the plastic surgeon makes the assessment of the flap, he/she will be unblinded in order to complete the reconstruction procedure using the same dissection device on the same side it was used for in the mastectomy procedure. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative flap perfusion will be recorded using SPY imaging system. Surgical site drainage will be measured until drainage removal. Post-operative pain (Visual Analog Scale for Pain) and the occurrence of adverse events will be recorded up until discharge and 30-days postoperative follow up visit.

Inclusion criteria

• Women aged 18-75 years.
• Choose bilateral mastectomy followed by immediate breast reconstruction.
• Have no inflammatory breast cancers.
• Have not had radiotherapy before mastectomy.
• Understand the study purpose, requirements, and risks.
• Be able and willing to give informed consent.

Exclusion criteria

• Active connective tissue disease.
• History of, or plan to undergo irradiation of the breasts.