Allogenic Acellular Dermal Matrix Use in Patients With Breast Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
研究概览
简要总结
Allogenic acellular dermal matrix has been used in burn injuries or abdominal walls reconstructions. However, it is solely used in breast reconstructions after breast carcinoma amputation. The efficacy of such allogenic dermal matrix can be advantageous when compared to current treatment options, however, this has to be proved.
详细描述
This is a prospective study, where patients undergoing breast reconstruction surgery using acellular dermal matrix (ADM) with expander use in first phase of reconstruction will be included. The permanent breast implants will be implanted approximately half year during second surgery. Acellular dermal matrix is a soft tissue graft that is formed by decellularization, however with intact extracellular dermal matrix. Such structure is able to re-create adequate skeleton for host cells with subsequent incorporation and revascularization. The safety and appropriateness of such ADM in breast reconstruction surgery will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •total one-side mastectomy due to breast cancer
- •age between 18-60 years
排除标准
- •failure to obtain signed informed consent
结局指标
主要结局
Number of complications in patients receiving acellular dermal matrix evaluated at 6 months after primary implantation
时间窗: 6 months
All patients between January 2010 and June 2014 undergoing primary ADM implantation will be evaluated at 6 months after implantation for early ex-plantations, inflammation, deformities of the implants, allergic reactions will be observed in patients undergoing primary ADM implantation at 6 months until second permanent implantation is performed.
次要结局
- Histologic evaluation of ADM implants upon planned explantations(6 months)
- Satisfaction with breast reconstruction outcome evaluated by Breast-Q questionnaire(2 years)
研究者
Julius Hodosy
Principal investigator
University Hospital Bratislava