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

January 17, 2018 updated by: Bradley Bengtson, M.D., Bengtson Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Bengtson Center for Aesthetics and Plastic Surgery
      • Grand Rapids, Michigan, United States, 49503
        • Center for Aesthetics and Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Age =>18 years

  • requesting procedure
  • No active cancer or infection

Exclusion Criteria:

  • Known allergy to silk
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nipple to Fold Measurement on Stretch
Time Frame: 1 year post op
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
Time Frame: 1 year post op
The percentage of breast tissue above and below the horizontal plane of the nipple over time
1 year post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bengtson Center

Collaborators

Allergan Medical

Investigators

  • Principal Investigator: Bradley P Bengtson, MD, Bengtson Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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