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

Recruiting now · Not applicable

Conditions studied: Wound Complication, Surgical Wound Infection, Post-operative Pain, Postoperative Complications, Scar

In brief

This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction. It is hypothesized that there will be no significant difference in mastectomy scar cosmesis. The purpose and objectives of this study are: 1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction. 2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

Key facts

Study ID: NCT06191159
Run by: University of British Columbia
People needed: 186
Starts: 2024-12-09
Expected to finish: 2025-12-01
Last updated by the study team: 2024-12-16

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients having a total mastectomy with or without axilla surgical staging

You may not qualify if…

Patients having immediate breast reconstruction
Patients with a diagnosis of inflammatory breast cancer
History of keloid scar formation
History of connective tissue disorder (scleroderma or rheumatoid arthritis with skin involvement)
Patients with prior incision at the planned mastectomy site.
Patients with known suture hypersensitivity
Patients with evidence of current infection

Where it is running

Mount Saint Joseph Hospital — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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