Macromastia Clinical Trial
— PRECISEOfficial title:
A Prospective, Randomized, Controlled Study to Evaluate Cutaneous Scar Quality Following Bilateral Breast Reduction With the PEAK PlasmaBlade 4.0
The objective of this clinical study is to evaluate scar quality following incision with the PEAK PlasmaBlade 4.0 using the Patient and Observer Scar Assessment Scale (POSAS), and to compare these results to equivalently-aged scars formed following incision with a standard scalpel.
Status | Terminated |
Enrollment | 13 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18 and 70 2. Physically healthy, stable weight 3. Non-smokers, or prior smokers who stopped smoking at least two weeks prior to surgery. 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. Subjects who have participated in the PEAK PlasmaBlade bilateral breast reduction study. Exclusion Criteria: 1. Age younger than 18 or greater than 70 years old 2. Anticoagulation therapy which cannot be discontinued 3. Smoking (continuous; any substance) 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 did not participated in the PEAK PlasmaBlade bilateral breast reduction study 13. Unable to follow instructions or complete follow-up |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Gupta Plastic Surgery | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Medtronic Surgical Technologies |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scar Quality | The primary endpoint will be the difference in scar quality (color, thickness, stiffness, pliability, etc.) between the scalpel and PlasmaBlade skin incisions. | 0-18 months following breast reduction surgery | No |
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