Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
NCT ID: NCT06191159
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
186 participants
INTERVENTIONAL
2024-12-09
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators propose a double blind prospective randomized controlled study of consecutive patients scheduled for total mastectomy +/- axilla staging without immediate breast reconstruction to evaluate the cosmetic scar result from the use of scalpel, standard electrocautery or PEAK PlasmaBlade.
Scar cosmesis will be evaluated postoperatively at two-to-four weeks, six months, and twelve months by two independent observers blinded to the equipment used, and patient reported outcomes will be reported using the validated SCAR-Q questionnaire.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard of Care
The Standard of Care arm will consist of the scalpel for the initial skin incision and further randomization to have completion of the surgery with standard electrocautery or PEAK PlasmaBlade.
Scalpel and standard electrocautery or PEAK PlasmaBlade
Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.
PEAK PlasmaBlade
PEAK PlasmaBlade for entire surgery.
Standard Electrocautery
Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.
Standard Electrocautery
Standard Electrocautery for entire surgery.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Scalpel and standard electrocautery or PEAK PlasmaBlade
Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
PEAK PlasmaBlade
PEAK PlasmaBlade for entire surgery.
Standard Electrocautery
Standard Electrocautery for entire surgery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carol Dingee
Breast Surgical Oncologist, Principal Investigator, Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol K Dingee, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Providence Health Care, University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Saint Joseph Hospital
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Carol K Dingee, MD, FRCSC
Role: primary
Carol K Dingee, MC, FRCSC
Role: backup
Amy K Bazzarelli, MD, FRCSC
Role: backup
Melina Deban, MD, FRCSC
Role: backup
Elaine C McKevitt, MD, FRCSC
Role: backup
Jieun Newman-Bremang, MD, FRCSC
Role: backup
Jin-Si Pao, MD, FRCSC
Role: backup
Rebecca Warburton, MD, FRCSC
Role: backup
Kathryn Isaac, MD, FRCSC
Role: backup
Lisa Aird, MD, FRCSC
Role: backup
Yuwei Yang, MSc
Role: backup
Bennett B Westmore
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H23-00115
Identifier Type: -
Identifier Source: org_study_id