NL-OMON55565已完成不适用
the BREAST trial (the Breast Reconstruction with External pre-expansion and Autologous fat transfer vs Standard Therapy trial) - the BREAST trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* Female gender
- •* Age of 18 years and older
- •* History or in candidate for a mastectomy procedure in the near future,
- •including patients undergoing a preventive mastectomy
- •* Patients* choice to undergo a breast reconstruction
- •* Wanting to participate in this study
- •* Patient is able to wear the BRAVA device
排除标准
- •* Active smoker or a history of smoking 4 weeks prior to surgery
- •* Current substance abuse
- •* History of lidocaine allergy
- •* History of silicone allergy
- •* 4 weeks or less after chemotherapy
- •* History of radiation therapy in the breast region
- •* Oncological treatment includes radiotherapy after mastectomy
- •* Kidney disease
- •* Steroid dependent asthma (daily or weekly) or other diseases
- •* Immune-suppressed or compromised disease
- •* Uncontrolled diabetes
- •* Large breast size (i.e. larger than cup C), unless the patient prefers
- •reduction of the contralateral side towards Cup C
- •* Extra-capsular silicone leaking from the encapsulated implant from a previous
- •breast reconstruction
- •* The treating plastic surgeon has strong doubts on the patient*s treatment
研究者
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撤回
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