NCT06191159

Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the superiority for cosmesis for PPB incision when compared to conventional electrocautery or scalpel. 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

• Wound Complication
• Surgical Wound Infection
• Post-operative Pain
• Postoperative Complications
• Scar

Interventions

Type	Name	Description
DEVICE	Scalpel and standard electrocautery or PEAK PlasmaBlade	Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
DEVICE	PEAK PlasmaBlade	PEAK PlasmaBlade for entire surgery.
DEVICE	Standard Electrocautery	Standard Electrocautery for entire surgery.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-01-05
• Last updated: 2024-12-16

Locations

1 site across 1 country: Canada