Macromastia (Symptomatic) Clinical Trial
Official title:
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Gonyon Cosmetic & Plastic Surgery, PC | Johnstown | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Surgical Technologies |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Difference in pain | 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. | 24 hours and first 10 days post-op | No |
| Secondary | Operative performance | Dissection time (normalized), estimated blood loss, use of traditional device for bleeding control, volume of tissue resection. | Intraoperatively on day 0 | No |
| Secondary | Adverse events | Monitoring for adverse events following surgery, including hematoma, seroma, wound dehiscence, etc. | 1 month post-operatively | Yes |
| Secondary | Cutaneous scarring | Scar width, quality, pigmentation, elevation, nodularity, thickness, and cosmetic appearance will be blindly evaluated by subject and independent observers. | Up to one year post-operatively | No |