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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

Locations
Other Locations
Canada
Mount Saint Joseph Hospital
RECRUITING
Vancouver
Contact Information
Primary
Carol K Dingee, MD, FRCSC
cdingee2@providencehealth.bc.ca
6048741141
Time Frame
Start Date: 2024-12-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 186
Treatments
Active_comparator: 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.
Experimental: PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.
Experimental: Standard Electrocautery
Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov

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