A Prospective Randomized and Controlled Study of Efficacy and Safety of TiLOOP® Bra Mesh in Patients With Expander-Implant Breast Reconstruction.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Complication Rates
研究概览
简要总结
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer
- •More than 18 years old
- •Karnofsky Performance Status (KPS) larger than 80
- •No clinical or imaging evidence of distant metastasis
- •BMI < 35kg/m2
- •Patients with no or mild breast ptosis
- •No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.
- •Mental Health Patient
排除标准
- •Patients with distant metastasis of breast cancer or local recurrence;
- •Past ipsilateral breast/chest wall radiation;
- •Inflammatory breast cancer, stage IV breast cancer
- •History of severe allergic or specific constitution;
- •Mental illness;
- •Drug/alcohol abuse;
- •Pregnancy, lactation, or impregnated during the trial period;
- •Non-eligible to the study enrollment based on researchers' discretion
结局指标
主要结局
Complication Rates
时间窗: up to 24 months after surgery
complications related to the reconstructed breast, including flap complications, capsular contracture, surgical site infection, prosthetic malposition/extrusion, reconstruction failure, etc.
Expansion Efficiency
时间窗: through study completion, an average of 1 year
percentage of average injected saline volume to total volume (E=average volume/ total volume）through study completion, an average of 1 year
次要结局
- number of occurrence of deep venous thrombosis(from expander implation up to the completion of expander exchange, through study completion, an average of 1 year)
- number of occurrence of non-surgical site infection(from expander implation up to the completion of expander exchange, through study completion, an average of 1 year)
- number of revision surgery(from the completion of expander exchange up to 24 months after surgery)
- psychological evaluation by Breast-Q questionnaire(from the completion of expander exchange up to 24 months after surgery)
- aesthetic outcome graded by Harris evaluation score and Breast-Q questionaire(from the completion of expander exchange up to 24 months after surgery)
- total cost(from expander implation up to the completion of expander exchange,through study completion, an average of 1 year)