The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
研究概览
简要总结
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
详细描述
Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •3.1.0 Ability to understand and the willingness to sign a written informed consent document.
- •3.1.1 Signed written informed consent.
- •3.1.2 Women with local or regional recurrences after previous breast conserving surgery.
- •3.1.3 Women undergoing delayed post mastectomy reconstruction.
- •3.1.4 Women undergoing prophylactic mastectomy.
- •3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.
- •3.1.6 Women of 18 years of age or older.
- •3.1.7 ECOG or Karnofsky Performance Status 0,1,
- •3.1.8 Basic Metabolic Panel within 6 months
- •3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
排除标准
- •3.2.1 History of liver or kidney failure will not be eligible.
- •3.2.2 Allergies to iodine containing products will not be eligible.
- •3.2.3 Women who are pregnant will not be eligible.
结局指标
主要结局
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
时间窗: 12 months
次要结局
- Establish the percentage of patients with ischemia or necrosis in the first year post surgery.(12 months)
- Number and type of complications in the first year.(12 months)