Mastectomy
Conditions
Keywords
Mastectomy, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).
Detailed description
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures. Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication a tissue drain is used to remove serous fluid from the surgical space via bulb suction. The rate of serous fluid collection is used to determine the time the drain remains in place. Although suction drains help reduce seroma formation, prolonged use may delay healing, cause injury, and increase the risk of infection and patient discomfort. The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like mastectomy. This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.
Interventions
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
DEVICEPEAK PlasmaBlade
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 20 and 70 years old 2. Physically healthy, stable weight 3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy 4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure 5. Subject must be willing and able to comply with all follow-up evaluations
Exclusion criteria
1. Age younger than 20 or greater than 70 years old 2. Anticoagulation therapy which cannot be discontinued 3. Prior external beam or implanted radiotherapy 4. Tobacco use (any kind) 5. Infection (local or systemic) 6. Cognitive impairment or mental illness 7. Severe cardiopulmonary deficiencies 8. Known coagulopathy 9. Immunocompromised 10. Kidney disease (any type) 11. Desiring or requiring same-day breast reconstruction 12. Prior breast reduction or augmentation surgery 13. Unable to follow instructions or complete follow-up 14. Currently taking any medication known to affect healing 15. Subjects who are status-post gastric banding or gastric bypass 16. Currently enrolled in another investigational device or drug trial 17. Time from most recent neoadjuvant therapy less than 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Serous Drainage (mL) From Time of Drain Placement to Removal. | 0 to 10 days postoperatively |
| Area of Skin Necrosis Measured With a Standard Ruler | 1 and 6 weeks postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal | 0 to 10 days postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care (SOC) Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection. | 30 |
| PEAK PlasmaBlade The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study termination | 30 | 30 |
Baseline characteristics
| Characteristic | Standard of Care (SOC) | PEAK PlasmaBlade | Total |
|---|---|---|---|
| Age, Customized 20 to 70 years | 30 participants | 30 participants | 60 participants |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Area of Skin Necrosis Measured With a Standard Ruler
Time frame: 1 and 6 weeks postoperative
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
Primary
Total Serous Drainage (mL) From Time of Drain Placement to Removal.
Time frame: 0 to 10 days postoperatively
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.
Secondary
Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal
Time frame: 0 to 10 days postoperatively
Population: An integrity audit found that the data for this study could not be analyzed owing to unverifiable source documentation.