The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Patient Satisfaction With the Procedure
研究概览
简要总结
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
详细描述
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All women who are candidates for breast reconstruction using tissue expanders after mastectomy
排除标准
- •Other forms of breast reconstruction after mastectomy
研究组 & 干预措施
DermaMatrix
experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
干预措施: DermaMatrix (Procedure)
Standard of care
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
干预措施: standard of care tissue expander breast reconstruction surgery after mastectomy (Procedure)
结局指标
主要结局
Patient Satisfaction With the Procedure
时间窗: one year from time of operation
Post Surgical Infection
时间窗: 4 weeks
Number of participants with post surgical infection
次要结局
未报告次要终点