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

Not Applicable

Recruiting

• Conditions: Postoperative Complications; Surgical Wound Infection; Wound Complication; Scar; Post-operative Pain
• Interventions: Device: Scalpel and standard electrocautery or PEAK PlasmaBlade; Device: Standard Electrocautery; Device: PEAK PlasmaBlade

• Registration Number: NCT06191159
• Lead Sponsor: University of British Columbia

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.

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.

Study Timeline

• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Status Verified: 2024-12
• Study Start: 2024-12-09
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Scalpel and standard electrocautery or PEAK PlasmaBlade	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.
Standard Electrocautery	Standard Electrocautery	Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.
PEAK PlasmaBlade	PEAK PlasmaBlade	The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.

Primary Outcome Measures

Name	Time	Method
Scar cosmesis (SCAR scale)	12 months post-operatively	Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by two independent observers blinded to the equipment used for the surgery using photo evaluation with the Scar Cosmesis Assessment and Rating (SCAR) scale. The SCAR scale yields scores ranging from a minimum score of 0 (best possible scar) to a maximum score of 15 (worst possible scar).
Scar cosmesis (Vancouver Scar Scale)	12 months post-operatively	Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by the treating surgeon using the Vancouver Scar Scale for physical examination. The Vancouver Scar Scale yields scores ranging from 0 (best) to 13 (worst).
Scar cosmesis (SCAR-Q)	12 months post-operatively	Patient reported outcomes will be reported 12 months post-operatively using the SCAR-Q scale, a comprehensive scar appearance scale with independently functioning domains for scar appearance, scar symptoms and psychosocial impact, which each yield transformed scores ranging from 0 (worst) to 100 (best).

Secondary Outcome Measures

Name	Time	Method
Development of cellulitis	within 12 months post-operatively	Development of post-operative cellulitis, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Wound infection rate	within 12 months post-operatively	Development of wound infection post-operatively.
Length of operative procedure	beginning to end of operative procedure	The duration of the operative procedure.
Peri-operative pain	from end of operative procedure to 2 weeks post-operatively	Peri-operative pain will be indicated by the medication prescribed and/or taken during post-anesthesia recovery (PAR) and surgical daycare.
Development of post-operative seroma	within 12 months post-operatively	Development of post-operative seroma, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Development of post-operative hematoma	within 12 months post-operatively	Development of post-operative hematoma, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Development of excessive bruising	within 12 months post-operatively	Development of post-operative excessive bruising, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Development of flap necrosis	within 12 months post-operatively	Development of post-operative flap-necrosis, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Development of wound dehiscence	within 12 months post-operatively	Development of post-operative wound dehiscence, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Delayed healing	within 12 months post-operatively	Delayed healing post-operatively, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Volume of measured drainage	from drain placement to drain removal, up to 1 month	Volume of drainage measured throughout drain duration. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.
Intraoperative blood loss	beginning to end of operative procedure	Volume of blood loss during the operative procedure.
Duration of drain	from drain placement to drain removal, up to 1 month	The total time between drain placement and removal. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.

Trial Locations

Locations (1)

Mount Saint Joseph Hospital; 🇨🇦 Vancouver, British Columbia, Canada