NL-OMON52848招募中不适用
External Vacuum Expansion: evaluation in breast reconstructive surgery - EVE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
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 64（—）
入选标准
- •- Female gender - Age of 18 years and older - History or in candidate for a
- •mastectomy procedure in the near future - Patients undergoing preventive
- •mastectomy - Patients* choice to undergo a breast reconstruction - Wanting to
- •participate in this study - Patient is able to wear the external expansion
排除标准
- •untreated breast cancer
- •history of radiation therapy on the involved breast, even if it was part of a
- •previous breast conservation procedure
- •completed chemotherapy course less than 2 months prior
- •except for the biopsy leading to the diagnosis of cancer, had surgery to
- •breast prior to the mastectomy
- •had mastectomy wound healing complications
- •mastectomy defect/scar has significant skin excess and deep folds adherent to
- •the chest wall
- •has a pacemaker or aneurysm clips
- •pregnancy or breastfeeding
- •had a cardiac stent placed within the last 2 months
- •claustrophobic
- •known current substance abuse
- •history of silicone allergy
- •history of Gadolinium allergy
- •history of lidocaine allergy
- •bleeding diathesis, whether primary or iatrogenic
- •cigarette smoker and/or Smokeless cigarette smokers
- •medical conditions that preclude breast reconstruction including uncontrolled
- •hypertension or diabetes, renal failure, steroid dependent asthma, and on
- •immuno- suppressant medications, as reported by patient
研究者
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