Clinical trial Recruiting at 1 site Interventional

Comparing scar outcomes from different incision techniques in mastectomy

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

Run by University of British Columbia · NCT06191159 · Data updated 2026-11-12

This study is testing which type of incision technique during mastectomy leads to the best-looking scars for patients who aren't having immediate breast reconstruction.

Quick facts

Study typeInterventional
SexAll
Enrollment186 (estimated)
SponsorUniversity of British Columbia
Academic / other
Locations1 site (Vancouver, British Columbia)
StatusRecruiting
StartedDecember 9, 2024
Main results expectedDecember 2025
Study endsDecember 2025
Registry record updatedDecember 16, 2024
Trial IDNCT06191159 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients scheduled for total mastectomy without immediate breast reconstruction.

Probably not a fit

Patients undergoing immediate breast reconstruction or those with specific medical histories such as keloid formation or current infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the cosmetic outcomes of surgical incisions made with scalpel, electrocautery, and PEAK PlasmaBlade during total mastectomy procedures without immediate breast reconstruction. It is a double-blind, prospective randomized controlled trial involving patients scheduled for mastectomy, where scar cosmesis will be assessed at multiple postoperative intervals by independent observers. The aim is to determine if there are significant differences in scar appearance between the three incision methods, potentially guiding future surgical practices.

Why it matters

Potential benefit: If successful, this study could lead to improved cosmetic outcomes for patients undergoing mastectomy.

How similar studies have gone: While various techniques for surgical incision have been studied, this specific comparison of PEAK PlasmaBlade against scalpel and electrocautery for cosmetic outcomes in mastectomy is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

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 skin involvement)
* Patients with prior incision at the planned mastectomy site.
* Patients with known suture hypersensitivity
* Patients with evidence of current infection

Where it's running

  • Mount Saint Joseph Hospital
    Vancouver, British Columbia, Canada
    Recruiting

Study contacts

  • Principal investigator: Carol K Dingee, MD, FRCSC — Providence Health Care, University of British Columbia
  • Study coordinator: Carol K Dingee, MD, FRCSC
  • Email: cdingee2@providencehealth.bc.ca
  • Phone: 6048741141

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.