Seri Surgical Scaffold Support of the Lower Pole of the Breast
- Conditions
- Recurrent Ptosis of the Breast
- Registration Number
- NCT02016612
- Lead Sponsor
- Bengtson Center
- Brief Summary
Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.
- Detailed Description
Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 76
Age =>18 years
- requesting procedure
- No active cancer or infection
- Known allergy to silk
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Nipple to Fold Measurement on Stretch 1 year post op The Nipple to fold will be measured manually over time to 1 year
- Secondary Outcome Measures
Name Time Method Percent Breast Tissue Above Nipple 1 year post op The percentage of breast tissue above and below the horizontal plane of the nipple over time
Trial Locations
- Locations (2)
Bengtson Center for Aesthetics and Plastic Surgery
🇺🇸Grand Rapids, Michigan, United States
Center for Aesthetics and Plastic Surgery
🇺🇸Grand Rapids, Michigan, United States
Bengtson Center for Aesthetics and Plastic Surgery🇺🇸Grand Rapids, Michigan, United States