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RECRUITING
NCT06191159
NA

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

Sponsor: University of British Columbia

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2024-12-09

Completion Date

2025-12

Last Updated

2024-12-16

Healthy Volunteers

No

Interventions

DEVICE

Scalpel and standard electrocautery or PEAK PlasmaBlade

Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.

DEVICE

PEAK PlasmaBlade

PEAK PlasmaBlade for entire surgery.

DEVICE

Standard Electrocautery

Standard Electrocautery for entire surgery.

Locations (1)

Mount Saint Joseph Hospital

Vancouver, British Columbia, Canada