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

NCT06191159 | Recruiting

• 1 other identifier: H23-00115
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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. 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. 2.To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

Conditions

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

Keywords

Electrocautery; PEAK PlasmaBlade; Scalpel; Mastectomy; Incision

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (13)

• Development of post-operative seroma

  within 12 months post-operatively

• Development of post-operative hematoma

  within 12 months post-operatively

• Development of excessive bruising

  within 12 months post-operatively

• Development of flap necrosis

  within 12 months post-operatively

• Development of wound dehiscence

  within 12 months post-operatively

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

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

PEAK PlasmaBlade

EXPERIMENTAL

The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.

Device: PEAK PlasmaBlade

Standard Electrocautery

EXPERIMENTAL

Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.

Device: Standard Electrocautery

Interventions

Scalpel and standard electrocautery or PEAK PlasmaBlade DEVICE

Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.

Standard of Care

PEAK PlasmaBlade DEVICE

PEAK PlasmaBlade for entire surgery.

PEAK PlasmaBlade

Standard Electrocautery DEVICE

Standard Electrocautery for entire surgery.

Standard Electrocautery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Mount Saint Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Pain, Postoperative; Postoperative Complications; Cicatrix; Surgical Wound

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Fibrosis; Wounds and Injuries

Study Officials

• Carol K Dingee, MD, FRCSC

  Providence Health Care, University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol K Dingee, MD, FRCSC

CONTACT

6048741141; cdingee2@providencehealth.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast Surgical Oncologist, Principal Investigator, Clinical Professor

Model Details: Patients will be randomized in equal numbers to have the initial skin incision made with either scalpel, standard electrocautery or PEAK PlasmaBlade. For skin incisions made with electrocautery or PEAK PlasmaBlade the surgeon will use the same equipment for the completion of the surgery. Patients who have initial skin incision with scalpel will be further randomized to have completion of the surgery with standard electrocautery or PEAK PlasmaBlade. Any patients with bilateral mastectomy will be randomized to the same surgical approach for both breasts.

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: December 9, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CA (1)