Actively Recruiting
A Randomized Controlled Trial Comparing the 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the cosmetic results of surgical scars from three different techniques used for initial skin incision during total mastectomy procedures without immediate breast reconstruction. The study compares the use of a scalpel, standard electrocautery, and the PEAK PlasmaBlade device. The goal is to determine if there is a significant difference in scar appearance among these methods and to inform future choices for breast surgery equipment. Participants will be randomly assigned to one of three groups: one using a scalpel for the initial incision followed by either standard electrocautery or PEAK PlasmaBlade to complete the surgery, one using PEAK PlasmaBlade for the entire surgery, and one using standard electrocautery for the entire surgery. The study is conducted as a double-blind, randomized controlled trial. Scar appearance will be assessed at 2 to 4 weeks, 6 months, and 12 months after surgery by two independent observers who do not know which device was used. Patients will also report their outcomes using the SCAR-Q questionnaire. Additional measures include monitoring for post-operative complications such as seroma, hematoma, bruising, wound infection, and pain, as well as operative time, blood loss, and drainage duration. The study is expected to run through December 2025.
CONDITIONS
Brief Title
Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients having a total mastectomy with or without axilla surgical staging
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the operative procedure
Participants undergo surgical breast incision using one of three methods: scalpel with standard electrocautery or PEAK PlasmaBlade, PEAK PlasmaBlade alone, or standard electrocautery alone.
1 visit (surgery day)
Duration - Up to 12 months post-operatively
Participants have their surgical scars assessed for cosmetic outcome and recovery. This includes evaluation of scar appearance and monitoring for complications such as seroma, hematoma, bruising, wound healing issues, and infection.
Visits at 2 to 4 weeks, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Mount Saint Joseph Hospital
Vancouver, British Columbia, Canada, V5T 3N4
Actively Recruiting
Research Team
C
Carol K Dingee, MD, FRCSC
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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