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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| PEAK PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision. |
|
| Standard Electrocautery | Experimental | Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scalpel and standard electrocautery or PEAK PlasmaBlade | Device | Scalpel followed by completion of surgery with standard electrocautery or PEAK PlasmaBlade. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol K Dingee, MD, FRCSC | Contact | 6048741141 | 78609 | cdingee2@providencehealth.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Carol K Dingee, MD, FRCSC | Providence Health Care, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Saint Joseph Hospital | Recruiting | Vancouver | British Columbia | V5T 3N4 | Canada |
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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.
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| PEAK PlasmaBlade | Device | PEAK PlasmaBlade for entire surgery. |
|
| Standard Electrocautery | Device | Standard Electrocautery for entire surgery. |
|
| 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). | 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). | 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). | 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). | 12 months post-operatively |
| 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). | 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). | 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). | 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). | 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). | 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). | within 12 months post-operatively |
| Wound infection rate | Development of wound infection post-operatively. | within 12 months post-operatively |
| Length of operative procedure | The duration of the operative procedure. | beginning to end of operative procedure |
| Intraoperative blood loss | Volume of blood loss during the operative procedure. | 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. | 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. | 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. | from drain placement to drain removal, up to 1 month |
| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D002921 | Cicatrix |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005355 | Fibrosis |
| D014947 | Wounds and Injuries |
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