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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of British Columbia

About this trial

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 criteria

Qualifiers

Patients having a total mastectomy with or without axilla surgical staging

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Scalpel and standard electrocautery or PEAK PlasmaBlade
  • PEAK PlasmaBlade
  • Standard Electrocautery

Treatment groups

186 Participants
are divided into 3 treatment groups

Sponsors and collaborators