Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 589
- 试验地点
- 4
- 主要终点
- Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist.
研究概览
简要总结
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro grafting breast augmentation and reconstruction procedures.
详细描述
Procedure:
Urine pregnancy test will be performed before each designated procedure in the study. Patients will be questioned about underlying renal disease and excluded if existent.
Pre-operative/baseline digital or 35mm photos will be obtained utilizing the standard criteria as performed routinely by plastic and reconstructive surgeons before any surgical procedure. Oblique, frontal and sagittal views will be stored in protected files.
Optional: Patients will have a preoperative breast MRI with the contrasting agent Gadolinium, utilizing a 1.5 Tesla MRI machine and breast coils unless status post breast cancer where no pre-operative MRI is needed. All readings will be performed by board certified radiologists.
Brava domes will be worn bilaterally 3-4 weeks before surgery for 10-12 hours per day, 7 days a week with 24 hour wear for the final 72 hours (3 days) before surgery. Patients will be required to adhere to the dome cleaning process specified by the manufacturer. This is prudent for hygienic reasons and to reduce skin irritation and infections. The domes are for single patient use only. Pressure will range from 15 mmHg to 105mmHg and will be achieved and regulated by either SmartBox, bulb syringe and/or Brava Turbo devices. This will open up the tissue planes and maximally expand the recipient breast in preparation for graft insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female volunteers between the ages of 18 and 80 years of age and weighing between 100- 275 lbs may be enrolled in the study. Ages 16 to 18 with developmental deformities may be enrolled with parental consent.
- •Post implant removal with subcutaneous defect
- •Post lumpectomy patients with or without radiation therapy with asymmetrical defect
- •Post mastectomy with or without radiation therapy
- •Post flap reconstruction with asymmetry or contour defect
- •Primary breast augmentation
- •Primary Post-mastectomy breast reconstruction
- •Breast asymmetry
- •Other congenital malformation of the breast such as constricted breasts, tubular breast, tuberous breasts, pectus associated deformities and Poland's Syndrome
排除标准
- •The following volunteers must be excluded from the study:
- •A volunteer who has a positive pregnancy test
- •A volunteer who has a pacemaker or aneurysm clips
- •A volunteer who has had a cardiac stent placed within the last two months
- •A volunteer who is claustrophobic
- •A volunteer with a known, current substance abuse
- •A volunteer with a history of silicone allergy
- •A volunteer with a history of Gadolinium allergy (if MRI performed)
- •A volunteer with a history of Lidocaine allergy
- •A volunteer with a bleeding diathesis
- •Untreated breast cancer
- •A volunteer who smokes cigarettes or who has a history of smoking within the past three (3) months.
- •Medical Conditions including Sever Hypertension, Renal disease, steroid dependant asthma, immuno-suppressed disease, Systemic Lupus, uncontrolled diabetes
结局指标
主要结局
Digital photographic interpretation by Board Certified Plastic Surgeon or Radiologist.
时间窗: 6 months
次要结局
- Patient's satisfaction with cosmetic and reconstructive result.(1 year)