Clinical trial NCT06191159: Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
Official title: A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound Complication
Surgical Wound Infection
Post-operative Pain
Postoperative Complications
Scar
Keywords: Electrocautery
PEAK PlasmaBlade
Scalpel
Mastectomy
Incision
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scar cosmesis (SCAR scale)
timeFrame: 2-4 weeks post-operatively
measure: Scar cosmesis (Vancouver Scar Scale)
timeFrame: 2-4 weeks post-operatively
measure: Scar cosmesis (SCAR-Q)
timeFrame: 2-4 weeks post-operatively
measure: Scar cosmesis (SCAR scale)
timeFrame: 6 months post-operatively
measure: Scar cosmesis (Vancouver Scar Scale)
timeFrame: 6 months post-operatively
measure: Scar cosmesis (SCAR-Q)
timeFrame: 6 months post-operatively
measure: Scar cosmesis (SCAR scale)
timeFrame: 12 months post-operatively
measure: Scar cosmesis (Vancouver Scar Scale)
timeFrame: 12 months post-operatively
measure: Scar cosmesis (SCAR-Q)
timeFrame: 12 months post-operatively
Secondary outcomes:
measure: Development of post-operative seroma
timeFrame: within 12 months post-operatively
measure: Development of post-operative hematoma
timeFrame: within 12 months post-operatively
measure: Development of excessive bruising
timeFrame: within 12 months post-operatively
measure: Development of flap necrosis
timeFrame: within 12 months post-operatively
measure: Development of wound dehiscence
timeFrame: within 12 months post-operatively
measure: Development of cellulitis
timeFrame: within 12 months post-operatively
measure: Delayed healing
timeFrame: within 12 months post-operatively
measure: Wound infection rate
timeFrame: within 12 months post-operatively
measure: Length of operative procedure
timeFrame: beginning to end of operative procedure
measure: Intraoperative blood loss
timeFrame: beginning to end of operative procedure
measure: Peri-operative pain
timeFrame: from end of operative procedure to 2 weeks post-operatively
measure: Duration of drain
timeFrame: from drain placement to drain removal, up to 1 month
measure: Volume of measured drainage
timeFrame: from drain placement to drain removal, up to 1 month
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Mount Saint Joseph Hospital
state: British Columbia
Study officials:
affiliation: Providence Health Care, University of British Columbia
name: Carol K Dingee, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: