EMPOwER: Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Nanomechanical properties of the skin and adjacent soft tissue
研究概览
简要总结
This study evaluates the skin and surrounding soft tissue that is removed during an implant reconstruction after a mastectomy.
详细描述
PRIMARY OBJECTIVE:
I. Characterize the nanomechanical properties of the skin and adjacent soft tissue removed at the time of postmastectomy implant reconstruction.
OUTLINE: This is an observational study.
Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Age 18 and older
- •Female sex
- •Patient with history of mastectomy with tissue expander placement
- •Tissue expander in place at time of study enrollment
- •Patient plans to undergo surgery to exchange tissue expander for permanent breast implant within the next 3 months of signing the informed consent
- •Ability to understand and provide written informed consent in accordance with institutional policies
排除标准
- 未提供
研究组 & 干预措施
Observational
Patients undergo tissue collection during standard of care surgery, have their medical records reviewed, and complete questionnaires throughout the study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Nanomechanical properties of the skin and adjacent soft tissue
时间窗: At time of surgery
The nanomechanical properties will be presented as a histogram that describes the characteristics of the sample. For each skin sample, summary statistics including mean (median), standard deviation, skewness, and range, mode, etc. will be used to describe the nanomechanical properties. Wilcoxon rank sum test or Fisher's exact test will be used to study the association between the summarized nanomechanical properties and clinical factors or outcomes. Pearson correlation coefficients will be used to assess the strength of association between any two continuous variables. Logistic regression will be conducted to examine the effect of nanomechanical properties on the risk of implant loss or any complication after adjusting other clinical factors.
次要结局
未报告次要终点