Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 4
- 主要终点
- Nipple to Fold Measurement on Stretch
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age =>18 years
- •requesting procedure
- •No active cancer or infection
排除标准
- •Known allergy to silk
- •Pregnant or lactating
研究组 & 干预措施
Reduction, Mastopexy No Implant, No Seri
Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used
干预措施: Seri Surgical Scaffold (Device)
Mastopexy, Implant no Seri Scaffold
Mastopexy with implant, No Seri Surgical Scaffold support is used
干预措施: Seri Surgical Scaffold (Device)
Breast Reduction with Seri Support
Patients undergoing breast reduction with the use of Seri Surgical scaffold support
干预措施: Seri Surgical Scaffold (Device)
Augmentation Mastopexy, Implant and Seri
Augmentation Mastopexy patients where Seri Surgical scaffold is used
干预措施: Seri Surgical Scaffold (Device)
结局指标
主要结局
Nipple to Fold Measurement on Stretch
时间窗: 1 year post op
The Nipple to fold will be measured manually over time to 1 year
次要结局
- Percent Breast Tissue Above Nipple(1 year post op)
研究者
Bradley Bengtson, M.D.
Bradley P Bengtson, MD FACS
Bengtson Center