NCT01372917已完成不适用
Evaluating Sterile Human Acellular Dermal Matrix in Immediate Expander-Based Breast Reconstruction: A Multi-centered Prospective Cohort Study
National Center for Plastic Surgery, Virginia1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
The study is a prospective multi-centered cohort study designed to determine the safety and efficacy of AlloMax in immediate expander-based breast reconstruction. Specifically, the study is designed to determine if sterility of human acellular dermal matrix results in a lower incidence of infection and seroma. The study will determine if gamma radiation, as a method of terminally sterilizing human acellular dermal matrix, has a negative impact on graft incorporation into the host tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients having immediate breast reconstruction with tissue expanders
- •Unilateral or bilateral reconstructions
- •Ages 25 - 65
- •All breast cancer stages and types
排除标准
- •BMI > 35
- •Active smokers
- •Diabetics
- •History of radiation or planned radiation
- •Immunocompromised patients
研究者
Mark L. Venturi, MD FACS
Physician
National Center for Plastic Surgery, Virginia
研究点 (1)
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