NCT01679223Unknown不适用
Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neoangiogenesis
研究概览
简要总结
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.
排除标准
- •Patients who do not agree to be included in the study.
结局指标
主要结局
Neoangiogenesis
时间窗: 3-4 months
Measure new blood vessels in AlloMaxTM and adjacent capsule
Hydroxyproline Concentration
时间窗: 3-4 months
Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
Collagen I and III
时间窗: 3-4 months
Measure collagen I and III in AlloMaxTM and adjacent capsule
次要结局
未报告次要终点
研究者
Kayvan Taghipour-Khiabani, M.D.
Tenured Associate Professor, Head of Hand and Microsurgery
University of Nevada, Las Vegas
研究点 (1)
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