Seri Surgical Scaffold Support of the Lower Pole of the Breast

Study Overview
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Brief Summary
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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
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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.

Official Title
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Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients

Conditions
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Recurrent Ptosis of the Breast

Intervention / Treatment
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* Device: Seri Surgical Scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age =>18 years requesting procedure No active cancer or infection Exclusion Criteria: Known allergy to silk Pregnant or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reduction, Mastopexy No Implant, No Seri<br>Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used | Device: Seri Surgical Scaffold<br>* An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.<br>* Other names: Seri Scaffold;|
| Active Comparator: Mastopexy, Implant no Seri Scaffold<br>Mastopexy with implant, No Seri Surgical Scaffold support is used | Device: Seri Surgical Scaffold<br>* An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.<br>* Other names: Seri Scaffold;|
| Active Comparator: Breast Reduction with Seri Support<br>Patients undergoing breast reduction with the use of Seri Surgical scaffold support | Device: Seri Surgical Scaffold<br>* An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.<br>* Other names: Seri Scaffold;|
| Active Comparator: Augmentation Mastopexy, Implant and Seri<br>Augmentation Mastopexy patients where Seri Surgical scaffold is used | Device: Seri Surgical Scaffold<br>* An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.<br>* Other names: Seri Scaffold;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nipple to Fold Measurement on Stretch | The Nipple to fold will be measured manually over time to 1 year | 1 year post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Breast Tissue Above Nipple | The percentage of breast tissue above and below the horizontal plane of the nipple over time | 1 year post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent, Ptosis, Reduction, Mammoplasty, Mastopexy