Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in patient satisfaction
研究概览
简要总结
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing the tissue expander above the muscle or below the muscle. The study will evaluate pain, wellbeing, and overall satisfaction with reconstruction. A secondary purpose is to learn whether there are differences in complications and costs between the two locations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Women at least 18 years of age, who will undergo immediate unilateral or bilateral implant-based breast reconstruction following therapeutic skin-sparing or nipple-sparing mastectomy.
- •Women at least 18 years of age, who will undergo immediate bilateral implant-based breast reconstruction following risk-reduction (prophylactic) skin-sparing or nipple-sparing mastectomy.
排除标准
- •Subjects who are unable to read or speak English.
- •Patients desiring autologous reconstruction.
- •History of radiation therapy to the breast(s), e.g. history of breast conservation therapy.
- •Current nicotine and/or tobacco use.
- •Documented diagnosis of chronic pain.
- •Women who are pregnant or breast-feeding *
- •Women who decline the use of acellular dermal matrix (ADM).
- •Surgeon decision not to proceed with tissue expander reconstruction.
- •Women undergoing single stage (straight to implant) reconstruction.
研究组 & 干预措施
Subcutaneous
Subcutaneous placement of tissue expander
干预措施: Subcutaneous placement (Procedure)
Submuscular
Submuscular placement of tissue expander
干预措施: Submuscular placement (Procedure)
结局指标
主要结局
Change in patient satisfaction
时间窗: Baseline, Year 3
Difference in patient satisfaction between the two groups using the physical well being scale.
次要结局
未报告次要终点
研究者
Minh-Doan Nguyen
Assistant Professor of Plastic Surgery
Mayo Clinic