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

NCT06191159 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2024-12-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Carol K Dingee, MD, FRCSC · Providence Health Care, University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06191159 on ClinicalTrials.gov