Protexa® Versus TiLoopBra® in Immediate Breast Reconstruction- A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- complications
研究概览
简要总结
Randomized controlled trial to look at early complications, cosmetic outcome, patient satisfaction and thickness of the tissue overlying the implant at the lower pole in immediate implant based breast reconstruction after Skin or Nipple Sparing Mastectomy with either a mesh (TiLOOP Bra) or an ADM (Protexa). Multicenter austrian trial with four breast cancer centers, 50 patients randomized 1:1 in the TiLoop or Protexa group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients with indication for skin or nipple sparing mastectomy
- •BRCA1/2 mutation carriers with indication for skin or nipple sparing mastectomy
排除标准
- •prior local radiotherapy
- •inflammatory breast cancer
结局指标
主要结局
complications
时间窗: 6 months after surgery
hematoma, seroma, infection, skin necrosis, capsular contracture, implant loss
change of baseline cosmetic outcome after 3 and 6 months
时间窗: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
four point Harris Scale (1=poor, 4=excellent)
change of baseline patient quality of life after 3 and 6 months
时间窗: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
questionnaire
change of baseline thickness of the tissue overlying the implant at the lower pole after 3 and 6 months
时间窗: up to two weeks after surgery (=baseline), 3 and 6 months after surgery
The thickness of the tissue covering the implant in the lower pole im mm measured by ultrasound
次要结局
未报告次要终点
研究者
Daphne Gschwantler-Kaulich
Ass.Prof.Dr.
Medical University of Vienna