Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
University of British Columbia
186 participants
Dec 9, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Patients having a total mastectomy with or without axilla surgical staging
Exclusion Criteria7
- 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
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Interventions
Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
PEAK PlasmaBlade for entire surgery.
Standard Electrocautery for entire surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06191159