Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- histology scoring
研究概览
简要总结
In this prospective study, breast capsule biopsy was performed in patients undergoing 2-stage expander-implant breast reconstruction to determine its use. Prospective clinical trial was designed for 10 consecutive patients as a pilot study and approved by IRB of Samsung Medical Center. From November 2013 to May 2015, full-thickness capsule biopsy specimen was obtained from acellular dermal matrix (ADM) capsule and from native subpectoral capsule (internal control) during expander-implant exchange. Biopsy specimens were scored for fibrosis and inflammatory reactions.
This is completed study and its specific title, study objective, method, and results will be available online after scientific journal submission.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 20 and 70
- •planning 2-stage expander-implant breast reconstruction using acellular dermal matrix
- •with no medical history such as diabetes, hypertension, or smoking
- •no surgical history
排除标准
- •newly detected medical or surgical condition
- •acellular dermal matrix loss due to allergic reaction or prosthetic infection
- •breast cancer recurrence
- •transfer to other institution
- •reconstruction give-up due to patient's wish
- •no biopsy score
结局指标
主要结局
histology scoring
时间窗: immediate after biopsy
semiquantitative histopathologic score system of biopsy specimens (reference: Basu et al., Plastic and Reconstructive Surgery, 126: 1842, 2010)
次要结局
未报告次要终点
研究者
Jai-Kyong Pyon
Professor, Principal Investigator
Samsung Medical Center