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Prospective Randomized Controlled Trial of Low-Power Ceramic Electrodissection vs. Traditional Electrocautery
Morgan Brgoch, MD, Jason Muelleck, BS, William Albright, MD, J Smith, MD, Donald Mackay, MD.
Penn State Hershey Medical Center, Hershey, PA, USA.
Various intraoperative dissection and coagulation techniques and devices exist within the standard operating procedure, however previously conducted studies have not led to surgeon consensus regarding impact on postoperative outcomes. Among these devices, low-power ceramic electrodissection (PEAK PlasmaBlade® ) is a relatively new dissection and coagulation technology indicated for use in a variety of surgical procedures, including mastectomy. In a previous retrospective review and case-control study of 52 complete mastectomies performed with utilization of the PEAK PlasmaBlade® vs. Bovie®, low-power ceramic electrodissection did not appear to offer any clinically significant advantage over traditional electrocautery. In this study, we aim to provide a higher level of evidence through a randomized clinical trial comparing perioperative and postoperative outcomes among patients having undergone complete mastectomy with use of a PEAK PlasmaBlade® compared to Bovie® electrocautery.
With approval from the Institutional Review Board, we conducted a prospective randomized clinical trial among patients undergoing complete mastectomy at a single tertiary institution. All patients scheduled to undergo complete mastectomies were identified during preoperative consultation. The enrollment period was from May 2015 through December 2015. Included patients were randomized for intraoperative dissection with either PlasmaBlade® or traditional electrocautery (Bovie® ). Patients remained blinded to the treatment received throughout the postoperative recovery. Perioperative and postoperative data collected includes: duration of total procedure, duration of mastectomy, drain output in the first 24 hours, pain scores within the first 24 hours, and incidence of surgical site infection (SSI), wound dehiscence, seroma, and hematoma occurring within the first 60 days postoperative. Recorded variables were evaluated with t-tests or chi-squared analysis when appropriate.
A total of 109 mastectomies met the study inclusion requirements, 6 were excluded from the trial at the patient’s request for a total of 103 mastectomies. Forty-eight mastectomies were randomized to the PlasmaBlade® treatment arm (n=48) and fifty-five mastectomies were randomized to the Bovie® arm (n=55). Patient demographics and comorbid conditions did not differ significantly between study arms. No significant differences between PlasmaBlade® and Bovie® cohorts were found with respect to: procedure duration (97.2 vs 103.4 min p=0.320), drain duration (14.2 vs 15.1 days p=0.217), 24 hours drain output (161.7 vs 156.9 mL p=0.778), hematoma rate (6.3% vs 5.5% OR-1.158 CI 0.222-6.013), skin or nipple loss rate (2.1% vs. 1.8% OR-1.149 CI 0.070-18.880), seroma rate (4.2% vs. 7.3% OR-.554 CI 0.097-3.170, or SSI rate (2.1% vs 5.5% OR-0.369 CI 0.037–3.668).
To date, this is the only prospective randomized controlled trial comparing the above postoperative outcomes among patients undergoing dissection with low-power ceramic electrodissection (PEAK PlasmaBlade®) vs. traditional electrocautery. Consistent with our previous case-control study of 52 mastectomies, low-power ceramic electrodissection does not appear to offer any clinical significant impact on operative time or postoperative outcomes despite the increased cost associated with its use.
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