Seri Surgical Scaffold Support of the Lower Pole of the Breast (SeriSupport)

Bengtson Center

Status: Completed

Conditions: Recurrent Ptosis of the Breast

Treatments: Device: Seri Surgical Scaffold

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02016612

007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age =>18 years

• requesting procedure
• No active cancer or infection

Exclusion criteria

• Known allergy to silk
• Pregnant or lactating

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 4 patient groups

Reduction, Mastopexy No Implant, No Seri

Active Comparator group

Description:

Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used

Treatment:

Device: Seri Surgical Scaffold

Mastopexy, Implant no Seri Scaffold

Active Comparator group

Description:

Mastopexy with implant, No Seri Surgical Scaffold support is used

Treatment:

Device: Seri Surgical Scaffold

Breast Reduction with Seri Support

Active Comparator group

Description:

Patients undergoing breast reduction with the use of Seri Surgical scaffold support

Treatment:

Device: Seri Surgical Scaffold

Augmentation Mastopexy, Implant and Seri

Active Comparator group

Description:

Augmentation Mastopexy patients where Seri Surgical scaffold is used

Treatment:

Device: Seri Surgical Scaffold