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

Last updated: December 10, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pressure Ulcer

Treatment

Scalpel and standard electrocautery or PEAK PlasmaBlade

PEAK PlasmaBlade

Standard Electrocautery

Clinical Study ID

NCT06191159
H23-00115
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients having a total mastectomy with or without axilla surgical staging

Exclusion

Exclusion Criteria:

  • 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 skininvolvement)

  • Patients with prior incision at the planned mastectomy site.

  • Patients with known suture hypersensitivity

  • Patients with evidence of current infection

Study Design

Total Participants: 186
Treatment Group(s): 3
Primary Treatment: Scalpel and standard electrocautery or PEAK PlasmaBlade
Phase:
Study Start date:
December 09, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel.

The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or PEAK PlasmaBlade.

Scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated SCAR-Q questionnaire.

Connect with a study center

  • Mount Saint Joseph Hospital

    Vancouver, British Columbia V5T 3N4
    Canada

    Active - Recruiting

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