Actively Recruiting

Phase Not Applicable
All Genders
NCT06191159

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

Led by University of British Columbia · Updated on 2024-12-16

186

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients having a total mastectomy with or without axilla surgical staging
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mount Saint Joseph Hospital

Vancouver, British Columbia, Canada, V5T 3N4

Actively Recruiting

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Research Team

C

Carol K Dingee, MD, FRCSC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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