Evaluation of the Effectiveness of the Prepectoral Breast Reconstruction With Braxon Dermal Matrix: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Satisfaction assessed by the BREAST-Q
研究概览
简要总结
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
详细描述
The study plans to compare conventional submuscular reconstruction with definitive implant and muscle sparing reconstruction with definitive implant in selected patients. The two techniques are compared in terms of patient quality of life and satisfaction; patient related outcomes, reconstruction morbidity, early and late complications are also investigated.
The study plans to collect robust data to support the prepectoral implant placement and complete coverage of implant with acellular dermal matrix in the clinical practice.
Consequently, the project plans to move toward evidence-based medicine in breast reconstruction, avoiding marketing influences and surgeon experience as the sole source of evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Informed consent
- •Not smokers
- •No vascular comorbidities (diabetic, vasculitis, coagulation disorders)
- •CUP B-C (or mastectomy estimated weight less than 550gm)
- •Good subcutaneous layer (>1cm on pinch test measured in upper/medial quadrant)
- •No previous breast surgery
- •No previous breast irradiation
- •Breast Ptosis 1-2 according to Renault's classification
- •DCIS tumors
- •T1 T2 pN0 breast tumor with known favourable biologic features
排除标准
- •Impossibility of immediate reconstruction with definitive implants due to inadequacy of mastectomy flaps (inadequate in quantity and/or quality)
- •Positive sentinel node biopsy requiring complete axillary dissection
结局指标
主要结局
Satisfaction assessed by the BREAST-Q
时间窗: 1 year
The BREAST-Q survey is used to detect differences in patient satisfaction among the groups
次要结局
- Immediate complications rate(1 month)
- Long term complications rate(24 months)
- Percentage of capsular contracture(1 year)
- Short term complications rate(6 months)