Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Incidence of Seroma
研究概览
简要总结
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
详细描述
The investigators' study aims to determine if there is a significant difference in postoperative outcomes when using DermACELL or AlloDerm, two acellular dermal matrix products, in breast reconstruction. Patients who are undergoing bilateral mastectomies with tissue expanders and acellular dermal matrix (ADM) with one of the investigators' two surgeons, Dr. Steven Davison or Dr. Ximena Pinell, are eligible to be enrolled. Patients' breasts will be randomized to receive either AlloDerm or DermACELL so that each patient had AlloDerm placed in one breast and DermACELL placed in the other on the day of surgery. Then, the following data for each breast will be recorded: time until drain removal, total drain output, time until first expander fill, and occurrences of infection and seroma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
At the time of surgery, the surgeon will be blinded to which acellular dermal matrix product he or she is utilizing in each breast, and the technical steps of the procedure will proceed identically on each side. This can be done through the help of circulators and scrub techs during the surgery, who can randomly prepare either AlloDerm or DermACELL to be placed in either the right or left breast, without informing the surgeon. Other items, like the selection of suture and number of drains placed will be at the discretion of the surgeon but will proceed identically in the two breasts.
Patients will also be blinded as to what product is in each breast. On the day of surgery, the circulator/operating room assistants will record what product is placed in each breast in the surgery electronic medical note.
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
- •Female patients over the age of 18
- •May be undergoing either therapeutic or prophylactic mastectomy
- •Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders
排除标准
- •Patients who wish to avoid the use of ADM in their reconstruction
- •History of radiation of the breast
- •Unilateral mastectomies
- •Direct to implant breast reconstruction (not utilizing a tissue expander)
结局指标
主要结局
Incidence of Seroma
时间窗: Up to 90 days
Each patient will be evaluated for incidence of seroma in either breast at postoperative visits.
Incidence of Infection
时间窗: Up to 90 days
Each patient will be evaluated for incidence of infection in either breast at postoperative visits.
Drain time
时间窗: Up to 90 days
Number of days between surgical placement of drains and time until drains are removed.
Drain output
时间窗: Up to 90 days
Total amount of fluid collected by the drains until their removal (measured in cc).
次要结局
- Incidence of Hematoma(Up to 90 days)
- Incidence of Skin necrosis(Up to 90 days)
- Incidence of Device Explantation(Up to 90 days)