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

Postoperative Complications Clinical Trial

— SCPPB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06191159
• Other study ID #: H23-00115
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of British Columbia
• Contact: Carol K Dingee, MD, FRCSC
• Phone: 6048741141
• Email: cdingee2[@]providencehealth.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 186
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain
• Postoperative Complications
• Scar
• Surgical Wound
• Surgical Wound Infection
• Wound Complication
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Mount Saint Joseph Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2-4 weeks post-operatively
Primary	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).	2-4 weeks post-operatively
Primary	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).	2-4 weeks post-operatively
Primary	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).	6 months post-operatively
Primary	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).	6 months post-operatively
Primary	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).	6 months post-operatively
Primary	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).	12 months post-operatively
Primary	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).	12 months post-operatively
Primary	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).	12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	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).	within 12 months post-operatively
Secondary	Wound infection rate	Development of wound infection post-operatively.	within 12 months post-operatively
Secondary	Length of operative procedure	The duration of the operative procedure.	beginning to end of operative procedure
Secondary	Intraoperative blood loss	Volume of blood loss during the operative procedure.	beginning to end of operative procedure
Secondary	Peri-operative pain	Peri-operative pain will be indicated by the medication prescribed and/or taken during post-anesthesia recovery (PAR) and surgical daycare.	from end of operative procedure to 2 weeks post-operatively
Secondary	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.	from drain placement to drain removal, up to 1 month
Secondary	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.	from drain placement to drain removal, up to 1 month