N/A
Completed N=137
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Recurrent Ptosis of the Breast
Source: ClinicalTrials.gov NCT02016612 ↗
Enrolled (actual)
137
Serious AEs
3.7%
Results posted
Feb 2018
Primary outcomePrimary: Nipple to Fold Measurement on Stretch — 2.3; 2.5; 1.4; 1.4 centimeters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nipple to Fold Measurement on Stretch |
2.3; 2.5; 1.4; 1.4 | — |
| SECONDARY Percent Breast Tissue Above Nipple |
35; 30; 15; 18 | — |
Eligibility Criteria
Inclusion Criteria
Age =>18 years
- requesting procedure
- No active cancer or infection
Exclusion Criteria
- Known allergy to silk
- Pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02016612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.