Macromastia
Conditions
Keywords
Breast Reduction, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
Brief summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
Detailed description
Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess tissue. The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing bilateral breast reduction. A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent prior to enrollment. Following enrollment, subject operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for bilateral breast reduction. Subjects were unaware of which device was used on which breast. Subjects were required to attend two follow-up visits after surgery, approximately one and six weeks following surgery.
Interventions
DEVICEPEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
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 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 20 and 60 2. Physically healthy, stable weight, non-smoker 3. Desiring bilateral breast reduction 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 specified follow-up evaluations. 6. Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.
Exclusion criteria
1. Age younger than 20 or greater than 60 years old 2. Anticoagulation therapy which cannot be discontinued 3. Smoking (any kind) 4. Infection (local or systemic) 5. Cognitive impairment or mental illness 6. Severe cardiopulmonary deficiencies 7. Known coagulopathy 8. Immunocompromised 9. Prior history of breast cancer 10. Kidney disease (any type) 11. Currently taking any medication known to affect healing 12. Subjects who are status-post gastric banding or gastric bypass 13. Currently enrolled in another investigational device or drug trial 14. Unable to follow instructions or complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 0 to 10 days postoperative | The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites. Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | Intraoperative | — |
| Operative Time | Intraoperative | — |
| Amount of Tissue Removed | Intraoperative | — |
| Dissection Performance | Intraoperative | Amount of tissue (g) removed over time (min) |
Countries
United States
Participant flow
Recruitment details
Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Total Study Population |
|---|---|
| Age Continuous | 41.12 years STANDARD_DEVIATION 14.2 |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 43 | 4 / 43 |
| serious Total, serious adverse events | 1 / 43 | 0 / 43 |
Outcome results
Primary
Postoperative Pain
The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites. Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.
Time frame: 0 to 10 days postoperative
Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Postoperative Pain | 4.47 units on a scale | Standard Deviation 2.05 |
| Standard of Care (SOC) | Postoperative Pain | 4.66 units on a scale | Standard Deviation 2.08 |
p-value: 0.4697t-test, 2 sided
Secondary
Amount of Tissue Removed
Time frame: Intraoperative
Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Amount of Tissue Removed | 685.92 g | Standard Deviation 347.08 |
| Standard of Care (SOC) | Amount of Tissue Removed | 649.18 g | Standard Deviation 322.07 |
p-value: 0.0776t-test, 2 sided
Secondary
Dissection Performance
Amount of tissue (g) removed over time (min)
Time frame: Intraoperative
Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Dissection Performance | 19.81 g/min | Standard Deviation 10.65 |
| Standard of Care (SOC) | Dissection Performance | 15.99 g/min | Standard Deviation 7.8 |
p-value: 0.0002t-test, 2 sided
Secondary
Estimated Blood Loss
Time frame: Intraoperative
Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Estimated Blood Loss | 56.59 mL | Standard Deviation 48.44 |
| Standard of Care (SOC) | Estimated Blood Loss | 64.27 mL | Standard Deviation 34.23 |
p-value: 0.147t-test, 2 sided
Secondary
Operative Time
Time frame: Intraoperative
Population: Two subjects were removed from the analysis of secondary variables owing to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Operative Time | 37.40 minutes | Standard Deviation 15.52 |
| Standard of Care (SOC) | Operative Time | 41.55 minutes | Standard Deviation 11.61 |
p-value: 0.0428t-test, 2 sided