Histological Analysis of AlloMend® Acellular Dermal Matrix Used During the Initial Pre Pectoral Placement of Tissue Expanders for Breast Reconstruction and Evaluated at Time of Permanent Breast Implantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AlloSource
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application
研究概览
简要总结
This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.
AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.
详细描述
The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.
This study will be performed at one (1) clinical center in the United States.
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
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age;
- •AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
- •Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
- •Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.
排除标准
- •Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
- •Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
结局指标
主要结局
AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application
时间窗: At expander/implant exchange surgery; typically 1-3 months post expander placement
The primary endpoint being evaluated in this study is AlloMend® Acellular Dermal Matrix graft incorporation when used in a soft tissue application. The endpoint will be analyzed from biopsied tissue samples taken during the exchange of expander to permanent breast implant using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen.
次要结局
- Seroma rates(Up to 6 months post expander/implant exchange)
- Revision surgeries(Up to 6 months post expander/implant exchange)
- Drain outputs and timing of drain removal(Up to 6 months post expander/implant exchange)
- Infection rates(Up to 6 months post expander/implant exchange)
- Hematoma rates(Up to 6 months post expander/implant exchange)