ISRCTN16902075进行中（未招募）2 期
A Mesh SAfety Platform for Immediate Implant-based BReAst Reconstruction (MAP-BRA) - Project 1. A multicentre prospective cohort study to evaluate the safety and effectiveness of Fortiva porcine acellular dermal matrix in immediate implant-based breast reconstruction
Royal Liverpool and Broadgreen University Hospital NHS Trust0 个研究点目标入组 79 人开始时间: 2020年1月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Women over the age of 18 undergoing mastectomy for invasive or pre-invasive breast cancer or risk reduction
- •2. Elect to undergo a sub-pectoral or pre-pectoral immediate implant-based reconstruction with mesh
排除标准
- •Patients undergoing:
- •1. Revisional surgery
- •2. Delayed breast reconstruction
- •3. Previous breast or mantle radiotherapy
- •4. Patients who are allergic to pork or unwilling to have a porcine product
- •5. Patients unable or unwilling to give informed consent
- •6. Patients considered by their surgeon to be unsuitable for mesh reconstruction
- •7. Patients who currently smoke cigarettes or e-cigarettes
- •8. Patients with a BMI of 35 or above
- •9. Patients in whom it is anticipated that an implant volume of greater than 500cc will be required
研究者
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