NCT06191159 Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
| NCT ID | NCT06191159 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Wound Complication |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2024-12-09 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Carol K Dingee, MD, FRCSC
PRINCIPAL INVESTIGATOR
Providence Health Care, University of British Columbia
Frequently Asked Questions
Who can join the NCT06191159 clinical trial?
This trial is open to participants of all sexes, studying Wound Complication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06191159 currently recruiting?
Yes, NCT06191159 is actively recruiting participants. Contact the research team at cdingee2@providencehealth.bc.ca for enrollment information.
Where is the NCT06191159 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT06191159 clinical trial?
NCT06191159 is sponsored by University of British Columbia. The principal investigator is Carol K Dingee, MD, FRCSC at Providence Health Care, University of British Columbia. The trial plans to enroll 186 participants.