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

University of British Columbia

Status: Enrolling

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

Treatments: Device: PEAK PlasmaBlade; Device: Scalpel and standard electrocautery or PEAK PlasmaBlade; Device: Standard Electrocautery

Study type: Interventional

Funder types: Other

Identifiers

NCT06191159

H23-00115

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Device: Scalpel and standard electrocautery or PEAK PlasmaBlade

PEAK PlasmaBlade

Experimental group

Description:

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

Treatment:

Device: PEAK PlasmaBlade

Standard Electrocautery

Experimental group

Description:

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

Treatment:

Device: Standard Electrocautery