Comparing Cosmetic Scars Using Scalpel, Electrocautery, and PEAK PlasmaBlade in Total Mastectomy Surgery Without Immediate Reconstruction

What this Trial Is About

Researchers are evaluating the cosmetic results of surgical scars from three different techniques used for initial skin incision during total mastectomy procedures without immediate breast reconstruction. The study compares the use of a scalpel, standard electrocautery, and the PEAK PlasmaBlade device. The goal is to determine if there is a significant difference in scar appearance among these methods and to inform future choices for breast surgery equipment. Participants will be randomly assigned to one of three groups one using a scalpel for the initial incision followed by either standard electrocautery or PEAK PlasmaBlade to complete the surgery, one using PEAK PlasmaBlade for the entire surgery, and one using standard electrocautery for the entire surgery. The study is conducted as a double-blind, randomized controlled trial. Scar appearance will be assessed at 2 to 4 weeks, 6 months, and 12 months after surgery by two independent observers who do not know which device was used. Patients will also report their outcomes using the SCAR-Q questionnaire. Additional measures include monitoring for post-operative complications such as seroma, hematoma, bruising, wound infection, and pain, as well as operative time, blood loss, and drainage duration. The study is expected to run through December 2025.

Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions