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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Surgical Wound Infection; Scar; Post-operative Pain; Wound Complication
• Intervention / Treatment: Device: Scalpel and standard electrocautery or PEAK PlasmaBlade; Device: PEAK PlasmaBlade; Device: Standard Electrocautery

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 Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol K Dingee, MD, FRCSC; Phone Number: 78609 6048741141; Email: cdingee2@providencehealth.bc.ca

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5T 3N4
      • Mount Saint Joseph Hospital
      • Contact: Carol K Dingee, MD, FRCSC; Phone Number: 78609 6048741141; Email: cdingee2@providencehealth.bc.ca
      • Principal Investigator: Carol K Dingee, MC, FRCSC
      • Sub-Investigator: Amy K Bazzarelli, MD, FRCSC
      • Sub-Investigator: Melina Deban, MD, FRCSC
      • Sub-Investigator: Elaine C McKevitt, MD, FRCSC
      • Sub-Investigator: Jieun Newman-Bremang, MD, FRCSC
      • Sub-Investigator: Jin-Si Pao, MD, FRCSC
      • Sub-Investigator: Rebecca Warburton, MD, FRCSC
      • Sub-Investigator: Kathryn Isaac, MD, FRCSC
      • Sub-Investigator: Lisa Aird, MD, FRCSC
      • Sub-Investigator: Yuwei Yang, MSc
      • Sub-Investigator: Bennett B Westmore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Scalpel and standard electrocautery or PEAK PlasmaBlade; Scalpel followed by completion of 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.	Device: PEAK PlasmaBlade; PEAK PlasmaBlade for entire surgery.
Experimental: Standard Electrocautery; Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.	Device: Standard Electrocautery; Standard Electrocautery for entire surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar cosmesis (SCAR scale)	Mastectomy site scar cosmesis will be evaluated 2-4 weeks 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).	2-4 weeks post-operatively
Scar cosmesis (Vancouver Scar Scale)	Mastectomy site scar cosmesis will be evaluated 2-4 weeks 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).	2-4 weeks post-operatively
Scar cosmesis (SCAR-Q)	Patient reported outcomes will be reported 2-4 weeks 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).	2-4 weeks post-operatively
Scar cosmesis (SCAR scale)	Mastectomy site scar cosmesis will be evaluated 6 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).	6 months post-operatively
Scar cosmesis (Vancouver Scar Scale)	Mastectomy site scar cosmesis will be evaluated 6 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).	6 months post-operatively
Scar cosmesis (SCAR-Q)	Patient reported outcomes will be reported 6 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).	6 months post-operatively
Scar cosmesis (SCAR scale)	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).	12 months post-operatively
Scar cosmesis (Vancouver Scar Scale)	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).	12 months post-operatively
Scar cosmesis (SCAR-Q)	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).	12 months post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of post-operative seroma	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).	within 12 months post-operatively
Development of post-operative hematoma	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).	within 12 months post-operatively
Development of excessive bruising	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).	within 12 months post-operatively
Development of flap necrosis	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).	within 12 months post-operatively
Development of wound dehiscence	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).	within 12 months post-operatively
Development of cellulitis	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).	within 12 months post-operatively
Delayed healing	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).	within 12 months post-operatively
Wound infection rate	Development of wound infection post-operatively.	within 12 months post-operatively
Length of operative procedure	The duration of the operative procedure.	beginning to end of operative procedure
Intraoperative blood loss	Volume of blood loss during the operative procedure.	beginning to end of operative procedure
Peri-operative pain	Peri-operative pain will be indicated by the medication prescribed and/or taken during post-anesthesia recovery (PAR) and surgical daycare.	from end of operative procedure to 2 weeks post-operatively
Duration of drain	The total time between drain placement and removal. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.	from drain placement to drain removal, up to 1 month
Volume of measured drainage	Volume of drainage measured throughout drain duration. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.	from drain placement to drain removal, up to 1 month

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Carol K Dingee, MD, FRCSC, Providence Health Care, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 20, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mastectomy; Incision; Electrocautery; Scalpel; PEAK PlasmaBlade
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Pain; Neurologic Manifestations; Pain, Postoperative; Wounds and Injuries; Surgical Wound; Postoperative Complications; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: H23-00115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes