Recruiting

Electrocautery, Scalpel, PEAK PlasmaBlade

Sponsor:

University of British Columbia

Code:

NCT06191159

Conditions

Wound Complication

Surgical Wound Infection

Post-operative Pain

Postoperative Complications

Scar

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Scalpel and standard electrocautery or PEAK PlasmaBlade

PEAK PlasmaBlade

Standard Electrocautery

Study Details

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.

Conditions

Wound Complication

Surgical Wound Infection

Post-operative Pain

Postoperative Complications

Scar

Study ID

NCT06191159

Start date

Dec 9, 2024

Status verified date

Dec, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

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.

experimental: PEAK PlasmaBlade

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

experimental: Standard Electrocautery

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

Interventions

Scalpel and standard electrocautery or PEAK PlasmaBlade

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

PEAK PlasmaBlade

PEAK PlasmaBlade for entire surgery.

Standard Electrocautery

Standard Electrocautery for entire surgery.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Carol K Dingee, MD, FRCSC

6048741141cdingee2@providencehealth.bc.ca

Locations

Mount Saint Joseph Hospital

Recruiting

Vancouver, British Columbia, Canada, V5T 3N4

Contacts

Carol K Dingee, MD, FRCSC

6048741141cdingee2@providencehealth.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Keywords

  • Electrocautery
  • PEAK PlasmaBlade
  • Scalpel
  • Mastectomy
  • Incision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-12-16.