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NCT Number: NCT06191159

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.

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Key information

Conditions

Wound Complication Cicatrix Fibrosis Infections Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-operative Pain Postoperative Complications Scar Signs and Symptoms Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Saint Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location status: Recruiting

Location contact

Amy K Bazzarelli, MD, FRCSC

CONTACT

Bennett B Westmore

CONTACT

Carol K Dingee, MC, FRCSC

CONTACT

Carol K Dingee, MD, FRCSC

CONTACT

[email protected]

6048741141 ext. 78609

Elaine C McKevitt, MD, FRCSC

CONTACT

Jieun Newman-Bremang, MD, FRCSC

CONTACT

Jin-Si Pao, MD, FRCSC

CONTACT

Kathryn Isaac, MD, FRCSC

CONTACT

Lisa Aird, MD, FRCSC

CONTACT

Melina Deban, MD, FRCSC

CONTACT

Rebecca Warburton, MD, FRCSC

CONTACT

Yuwei Yang, MSc

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalpel and standard electrocautery or PEAK PlasmaBlade

Device

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

PEAK PlasmaBlade

Device

PEAK PlasmaBlade for entire surgery.

Standard Electrocautery

Device

Standard Electrocautery for entire surgery.

Primary outcomes

  1. Scar cosmesis (SCAR scale)

    Time frame: 2-4 weeks post-operatively

    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. Scar cosmesis (Vancouver Scar Scale)

    Time frame: 2-4 weeks post-operatively

    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).

  3. Scar cosmesis (SCAR-Q)

    Time frame: 2-4 weeks post-operatively

    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).

  4. Scar cosmesis (SCAR scale)

    Time frame: 6 months post-operatively

    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).

  5. Scar cosmesis (Vancouver Scar Scale)

    Time frame: 6 months post-operatively

    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. Scar cosmesis (SCAR-Q)

    Time frame: 6 months post-operatively

    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).

  7. Scar cosmesis (SCAR scale)

    Time frame: 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).

  8. Scar cosmesis (Vancouver Scar Scale)

    Time frame: 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).

  9. Scar cosmesis (SCAR-Q)

    Time frame: 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 outcomes

  1. Development of post-operative seroma

    Time frame: 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).

  2. Development of post-operative hematoma

    Time frame: 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).

  3. Development of excessive bruising

    Time frame: 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).

  4. Development of flap necrosis

    Time frame: 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).

  5. Development of wound dehiscence

    Time frame: 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).

  6. Development of cellulitis

    Time frame: 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).

  7. Delayed healing

    Time frame: 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).

  8. Wound infection rate

    Time frame: within 12 months post-operatively

    Development of wound infection post-operatively.

  9. Length of operative procedure

    Time frame: beginning to end of operative procedure

    The duration of the operative procedure.

  10. Intraoperative blood loss

    Time frame: beginning to end of operative procedure

    Volume of blood loss during the operative procedure.

  11. Peri-operative pain

    Time frame: 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.

  12. Duration of drain

    Time frame: 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.

  13. Volume of measured drainage

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol K Dingee, MD, FRCSC

CONTACT

[email protected]

6048741141 ext. 78609

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: SCPPB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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