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Recruiting NCT06191159

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

No phase Interventional Wound Complication Surgical Wound Infection Post-operative Pain Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scalpel and standard electrocautery or PEAK PlasmaBlade, PEAK PlasmaBlade, Standard Electrocautery.
Who it may be relevant to
Registry conditions: Wound Complication, Surgical Wound Infection, Post-operative Pain, Postoperative Complications. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device Scalpel and standard electrocautery or PEAK PlasmaBlade
    Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
  • Device PEAK PlasmaBlade
    PEAK PlasmaBlade for entire surgery.
  • Device Standard Electrocautery
    Standard Electrocautery for entire surgery.

Primary outcome measures

  • Scar cosmesis (SCAR scale) [Time frame: 2-4 weeks post-operatively]
  • Scar cosmesis (Vancouver Scar Scale) [Time frame: 2-4 weeks post-operatively]
  • Scar cosmesis (SCAR-Q) [Time frame: 2-4 weeks post-operatively]
  • Scar cosmesis (SCAR scale) [Time frame: 6 months post-operatively]
  • Scar cosmesis (Vancouver Scar Scale) [Time frame: 6 months post-operatively]
  • Scar cosmesis (SCAR-Q) [Time frame: 6 months post-operatively]
  • Scar cosmesis (SCAR scale) [Time frame: 12 months post-operatively]
  • Scar cosmesis (Vancouver Scar Scale) [Time frame: 12 months post-operatively]
  • Scar cosmesis (SCAR-Q) [Time frame: 12 months post-operatively]
Secondary outcome measures (12)
  • Development of post-operative seroma [Time frame: within 12 months post-operatively]
  • Development of post-operative hematoma [Time frame: within 12 months post-operatively]
  • Development of excessive bruising [Time frame: within 12 months post-operatively]
  • Development of flap necrosis [Time frame: within 12 months post-operatively]
  • Development of wound dehiscence [Time frame: within 12 months post-operatively]
  • Development of cellulitis [Time frame: within 12 months post-operatively]
  • Delayed healing [Time frame: within 12 months post-operatively]
  • Wound infection rate [Time frame: within 12 months post-operatively]
  • Length of operative procedure [Time frame: beginning to end of operative procedure]
  • Intraoperative blood loss [Time frame: beginning to end of operative procedure]
  • Peri-operative pain [Time frame: from end of operative procedure to 2 weeks post-operatively]
  • Duration of drain [Time frame: from drain placement to drain removal, up to 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Mount Saint Joseph Hospital — Vancouver

Identifiers

NCT: NCT06191159 · H23-00115

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗