Macromastia (Symptomatic)
Conditions
Keywords
Reduction mammaplasty, Breast reduction, PlasmaBlade, PEAK
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 to compare these outcomes to the HARMONIC SYNERGY® BLADE.
Interventions
DEVICEPEAK PlasmaBlade
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age between 18 and 70 2. Physically healthy, stable weight 3. No smoking \<1 month prior to surgery and during study. 4. Desiring bilateral breast reduction 5. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 6. Subject must be willing and able to comply with specified follow-up evaluations. 7. Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.
Exclusion criteria
1. Age younger than 18 or greater than 70 years old 2. Anticoagulation therapy which cannot be discontinued 3. Smoking \<1 month prior to surgery or during study 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 |
|---|---|---|
| Difference in pain | 24 hours and first 10 days post-op | The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cutaneous scarring | Up to one year post-operatively | Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers. |
| Operative performance | Intraoperatively on day 0 | Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection. |
| Adverse events | 1 month post-operatively | Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc. |
Countries
United States
Outcome results
None listed