A Randomized Controlled Trial of Prepectoral Versus Subpectoral Prosthetic Breast Reconstruction
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 13
- 主要终点
- major perioperative complications
研究概览
简要总结
The purpose of this study is to compare two standard techniques for breast reconstruction-the prepectoral technique and the subpectoral technique. Again, the prepectoral technique involves putting a tissue expander on top of the pectoralis muscle, while the subpectoral technique involves putting a tissue expander under the pectoralis muscle.
The standard approach used at MSK is the subpectoral technique. This study will help researchers find out whether the subpectoral approach is better, the same as, or worse than the prepectoral approach. To decide which approach is better, the researchers will look at which technique causes fewer complications after surgery (for example, infection or the need for a second surgery). Researchers are also interested in seeing which approach causes less pain and use of pain medication after surgery.
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
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 21-60 years
- •Planning to undergo immediate two stage prosthetic breast reconstruction with TE placement as the first stage.
- •Planning to undergo unilateral or bilateral mastectomy.
- •Planning to undergo nipple- or skin-sparing mastectomy.
- •Mastectomy weight less than 800 grams.
- •Adequate mastectomy skin perfusion or patients with adequate perfusion but nonviable mastectomy skin that can be excised (≤ 4 cm) at the defect margins with otherwise adequate perfusion.
排除标准
- •Receipt of neoadjuvant chemotherapy for locally advanced breast cancer.
- •Presence of preoperative axillary lymph node metastasis.
- •Presence of intraoperative sentinel node positivity.
- •History of radiotherapy.
- •Current smoker.
- •Planning to undergo direct-to-implant reconstruction.
- •Prior sternotomy.
结局指标
主要结局
major perioperative complications
时间窗: 90 days
90-day major complications for tissue expanders (i.e., infection, explantation, and reoperation for mastectomy flap necrosis): * Infection: any event requiring restart of antibiotics (oral or intravenous) following completion of initial perioperative antibiotics or an admission to the hospital for cellulitis. * Explantation: need for tissue expander removal for any cause. * Reoperation: skin excision performed in either the clinic or the main operating room for mastectomy skin flap necrosis.
次要结局
- minor complications(90 days)