Wound ComplicationSCPPBNCT06191159
Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
A study testing Scalpel and standard electrocautery or PEAK PlasmaBlade, PEAK PlasmaBlade and Standard Electrocautery in people with Wound Complication and Surgical Wound Infection, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Complication, Surgical Wound Infection, Post-operative Pain
- What is being tested?
- Scalpel and standard electrocautery or PEAK PlasmaBlade, PEAK PlasmaBlade and Standard Electrocautery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2024to Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having a total mastectomy with or without axilla surgical staging
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Saint Joseph Hospital
Vancouver, British Columbia, V5T 3N4
Carol K Dingee, MD, FRCSC, 6048741141 ext. 78609, cdingee2@providencehealth.bc.ca
Carol K Dingee, MC, FRCSC
About this study
Official title: A Randomized Controlled Trial Comparing the Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions
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.
Read more
The purpose and objectives of this study are:
- 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.
- To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.
Read the 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.
- Conditions
- Wound Complication, Surgical Wound Infection, Post-operative Pain, Postoperative Complications, Scar
- Being tested
- Scalpel and standard electrocautery or PEAK PlasmaBlade, PEAK PlasmaBlade, Standard Electrocautery
- Keywords
- Electrocautery, PEAK PlasmaBlade, Scalpel, Mastectomy, Incision
- Medical subject headings
- Surgical Wound Infection, Pain, Postoperative, Postoperative Complications, Cicatrix, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalpel and standard electrocautery or PEAK PlasmaBladeDevice
Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade.
PEAK PlasmaBladeDevice
PEAK PlasmaBlade for entire surgery.
Standard ElectrocauteryDevice
Standard Electrocautery for entire surgery.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | 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. Receives: Device: Scalpel and standard electrocautery or PEAK PlasmaBlade |
| PEAK PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision. Receives: Device: PEAK PlasmaBlade |
| Standard Electrocautery | Experimental | Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision. Receives: Device: Standard Electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar cosmesis (SCAR scale)
Mastectomy site scar cosmesis will be evaluated 2-4 weeks post-operatively by two independent observers blinded to the equipment used for the surgery using photo evaluation with the Scar Cosmesis Assessment and Rating (SCAR) scale. The SCAR scale yields scores ranging from a minimum score of 0 (best possible scar) to a maximum score of 15 (worst possible scar).
Measured: 2-4 weeks post-operatively
Scar cosmesis (Vancouver Scar Scale)
Mastectomy site scar cosmesis will be evaluated 2-4 weeks post-operatively by the treating surgeon using the Vancouver Scar Scale for physical examination. The Vancouver Scar Scale yields scores ranging from 0 (best) to 13 (worst).
Measured: 2-4 weeks post-operatively
Scar cosmesis (SCAR-Q)
Patient reported outcomes will be reported 2-4 weeks post-operatively using the SCAR-Q scale, a comprehensive scar appearance scale with independently functioning domains for scar appearance, scar symptoms and psychosocial impact, which each yield transformed scores ranging from 0 (worst) to 100 (best).
Measured: 2-4 weeks post-operatively
Scar cosmesis (SCAR scale)
Mastectomy site scar cosmesis will be evaluated 6 months post-operatively by two independent observers blinded to the equipment used for the surgery using photo evaluation with the Scar Cosmesis Assessment and Rating (SCAR) scale. The SCAR scale yields scores ranging from a minimum score of 0 (best possible scar) to a maximum score of 15 (worst possible scar).
Measured: 6 months post-operatively
Scar cosmesis (Vancouver Scar Scale)
Mastectomy site scar cosmesis will be evaluated 6 months post-operatively by the treating surgeon using the Vancouver Scar Scale for physical examination. The Vancouver Scar Scale yields scores ranging from 0 (best) to 13 (worst).
Measured: 6 months post-operatively
Scar cosmesis (SCAR-Q)
Patient reported outcomes will be reported 6 months post-operatively using the SCAR-Q scale, a comprehensive scar appearance scale with independently functioning domains for scar appearance, scar symptoms and psychosocial impact, which each yield transformed scores ranging from 0 (worst) to 100 (best).
Measured: 6 months post-operatively
Scar cosmesis (SCAR scale)
Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by two independent observers blinded to the equipment used for the surgery using photo evaluation with the Scar Cosmesis Assessment and Rating (SCAR) scale. The SCAR scale yields scores ranging from a minimum score of 0 (best possible scar) to a maximum score of 15 (worst possible scar).
Measured: 12 months post-operatively
Scar cosmesis (Vancouver Scar Scale)
Mastectomy site scar cosmesis will be evaluated 12 months post-operatively by the treating surgeon using the Vancouver Scar Scale for physical examination. The Vancouver Scar Scale yields scores ranging from 0 (best) to 13 (worst).
Measured: 12 months post-operatively
Scar cosmesis (SCAR-Q)
Patient reported outcomes will be reported 12 months post-operatively using the SCAR-Q scale, a comprehensive scar appearance scale with independently functioning domains for scar appearance, scar symptoms and psychosocial impact, which each yield transformed scores ranging from 0 (worst) to 100 (best).
Measured: 12 months post-operatively
Secondary outcomes (13)
Development of post-operative seroma
Development of post-operative seroma, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Development of post-operative hematoma
Development of post-operative hematoma, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Development of excessive bruising
Development of post-operative excessive bruising, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Development of flap necrosis
Development of post-operative flap-necrosis, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Development of wound dehiscence
Development of post-operative wound dehiscence, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Development of cellulitis
Development of post-operative cellulitis, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Delayed healing
Delayed healing post-operatively, graded using the Clavien-Dindo classification system for surgical complications. The Clavien-Dindo classification of surgical complications ranges from Grade I (any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions) to Grade V (death of a patient).
Measured: within 12 months post-operatively
Wound infection rate
Development of wound infection post-operatively.
Measured: within 12 months post-operatively
Length of operative procedure
The duration of the operative procedure.
Measured: beginning to end of operative procedure
Intraoperative blood loss
Volume of blood loss during the operative procedure.
Measured: beginning to end of operative procedure
Peri-operative pain
Peri-operative pain will be indicated by the medication prescribed and/or taken during post-anesthesia recovery (PAR) and surgical daycare.
Measured: from end of operative procedure to 2 weeks post-operatively
Duration of drain
The total time between drain placement and removal. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.
Measured: from drain placement to drain removal, up to 1 month
Volume of measured drainage
Volume of drainage measured throughout drain duration. Drain removal will occur when less than 30 mL of drainage accumulates for two consecutive days.
Measured: from drain placement to drain removal, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start9 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound ComplicationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Dingee, University of British Columbia
- Investigators
- Carol K Dingee, MD, FRCSC, Principal investigator, Providence Health Care, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191159
- Sponsor's protocol ID
- H23-00115
- Acronym
- SCPPB
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No