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Completed

NCT Number: NCT02016612

Seri Surgical Scaffold Support of the Lower Pole of the Breast

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.

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Key information

Conditions

Recurrent Ptosis of the Breast Blepharoptosis Disease Attributes Eye Diseases Eyelid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age =>18 years

  • requesting procedure
  • No active cancer or infection

Exclusion criteria

  • Known allergy to silk
  • Pregnant or lactating

Treatment and study plan

Seri Surgical Scaffold

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bengtson Center

Other

Collaborators

  • Allergan Medical

Registry information

Official study title

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

Acronym: SeriSupport

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 20, 2013
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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