A Study to Evaluate the Safety and Effectiveness of AlloMend® Acellular Dermal Matrix Used in Post Mastectomy Pre-Pectoral Breast Reconstruction and Followed for Up To 12-Months Post-Operatively
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
- 100
- 试验地点
- 1
- 主要终点
- Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
研究概览
简要总结
This retrospective, single-site study will provide information regarding the efficiency of AlloMend® Acellular Dermal Matrix allograft in Pre-Pectoral Breast Reconstruction surgery following a single or double mastectomy.
详细描述
AlloMend® Acellular Dermal Matrix AlloMend® is a sterile, ready-to-use, human-derived acellular dermal matrix (ADM) allograft that can be used in a number of reconstructive and other surgical procedures. It is made from donated human full-thickness skin. After the epidermal and hypodermal layers are removed, the tissue is treated by a proprietary cleansing process.
AlloMend® is intended to be used in conjunction with a breast implant or tissue expander to stabilize implant position and minimize implant loss during post-single or double mastectomy, unilateral or bilateral pre-pectoral breast reconstruction in women 18 years of age or older. AlloMend® may be used in either one-stage (direct-to-implant) or two-stage (expander-to-implant) procedures.
This retrospective study will be performed at one center in the United States.
Information from the preoperative clinical visit and Pre-Pectoral Breast Reconstruction surgery utilizing AlloMend® Acellular Dermal Matrix allograft, approximately 200 breasts (and up to 100 patients), and the follow-up clinical visits at approximately 2 weeks, 6 weeks, 3 months, 6 months, and 12 months, including clinical assessments, imaging, and patient-reported outcomes, will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients must meet the following inclusion criteria to participate in this study:
- •Female ≥ 18 years old.
- •Patients have undergone a single or double mastectomy, followed by AlloMend® Acellular Dermal Matrix -assisted, pre-pectoral breast reconstruction.
- •Patients have undergone either one-stage (direct-to-implant) or two-stage (expander-to-implant), unilateral or bilateral pre-pectoral breast reconstruction using AlloMend®.
排除标准
- •Patients must not meet any of the following criteria to be considered for this clinical trial:
- •Did not utilize AlloMend® Acellular Dermal Matrix allograft during pre-pectoral breast reconstruction
- •Did not have post-operative evaluations at the clinical site.
结局指标
主要结局
Retrospective Analysis of Clinical and Surgical Outcomes in Pre-Pectoral Breast Reconstruction with AlloMend®
时间窗: Up to 12-month post-operatively
This primary outcome measure will retrospectively collect descriptive data on patients who have undergone single or double mastectomy followed by pre-pectoral breast reconstruction using AlloMend® Acellular Dermal Matrix allograft. Data will be extracted from medical records and will include patient demographics, medical history, surgical techniques, intraoperative and postoperative complications, prescribed medications, and adjuvant treatments such as chemotherapy and radiation. The objective is to characterize patient profiles, surgical outcomes, and potential complications associated with this reconstructive approach.
次要结局
- Retrospective Assessment of Patient-Reported Health Status and Quality of Life(Up to 12 months)
- Retrospective Evaluation of Follow-Up Clinical, Imaging, and Surgical Outcomes(Up to 12-month post-operatively)