NL-OMON50674招募中不适用
ong-term results of two-stage breast reconstruction with polyurethane-covered versus textured implants: a prospective, multicenter randomized controlled trial - TIPI TRAIL: Textured Implants versus Polyurethane-covered Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 321
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
- •Age of 18 years or older
- •Mastectomy is performed
- •Eligible for two-stage implant-based breast reconstruction in accordance with
- •the Dutch national breast reconstruction guideline
- •First step of two-stage implant-based breast reconstruction (placement of
- •tissue expander) is successfully completed
- •Able to understand the patient information sheet, to complete questionnaires
- •and to provide written informed consent
排除标准
- •Additional use of autologous tissues for the breast reconstruction
- •The use of acellular dermal matrix or synthetic mesh
- •Prior irradiation of the breast or an indication for postoperative
- •radiotherapy (If a patient receives radiotherapy unexpectedly at a later point
- •in time, she will be excluded retroactively)
- •Secondary reconstruction
- •Revision surgery of a previous breast reconstruction
- •Inflammatory carcinoma
- •Evidence of distant metastases
- •Active infection at the surgical field or distant locations
研究者
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