RecruitingNot ApplicableNCT06191159

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


Sponsor

University of British Columbia

Enrollment

186 participants

Start Date

Dec 9, 2024

Study Type

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called PEAK PlasmaBlade, a medical device called Scalpel and standard electrocautery or PEAK PlasmaBlade, and others for people with post operative pain, postoperative complications, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEScalpel and standard electrocautery or PEAK PlasmaBlade

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

DEVICEPEAK PlasmaBlade

PEAK PlasmaBlade for entire surgery.

DEVICEStandard Electrocautery

Standard Electrocautery for entire surgery.


Locations(1)

Mount Saint Joseph Hospital

Vancouver, British Columbia, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06191159


Related Trials