Comparing scar outcomes from different incision techniques in mastectomy
A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06191159 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for total mastectomy without immediate breast reconstruction.
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.
Why it matters
Potential benefit: If successful, this study could lead to improved cosmetic outcomes for patients undergoing mastectomy.
How similar studies have performed: 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.
Eligibility criteria
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 this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.