Seri Surgical Scaffold Support of the Lower Pole of the Breast

Not Applicable

Completed

• Conditions: Recurrent Ptosis of the Breast
• Interventions: Device: Seri Surgical Scaffold

• 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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-20
• Primary Completion: 2015-11
• Results First Submitted: 2016-11-15
• Study Completion: 2016-11-30
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Results First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

Age =>18 years

• requesting procedure
• No active cancer or infection

Exclusion Criteria

• Known allergy to silk
• Pregnant or lactating

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reduction, Mastopexy No Implant, No Seri	Seri Surgical Scaffold	Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used
Augmentation Mastopexy, Implant and Seri	Seri Surgical Scaffold	Augmentation Mastopexy patients where Seri Surgical scaffold is used
Breast Reduction with Seri Support	Seri Surgical Scaffold	Patients undergoing breast reduction with the use of Seri Surgical scaffold support
Mastopexy, Implant no Seri Scaffold	Seri Surgical Scaffold	Mastopexy with implant, No Seri Surgical Scaffold support is used

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)

Center for Aesthetics and Plastic Surgery; 🇺🇸 Grand Rapids, Michigan, United States

Bengtson Center for Aesthetics and Plastic Surgery; 🇺🇸 Grand Rapids, Michigan, United States