Comparison of FlexHD and Alloderm Outcomes in Breast Reconstructive Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Wound Dehiscence
研究概览
简要总结
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction.
详细描述
FlexHD and Alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. There have been few chart review studies comparing outcomes between the two materials in breast reconstruction. These studies have determined there is no difference in complication rates between the two materials. However, there have never been any active studies to date. This study will serve as a randomized controlled trial comparing FlexHD and Alloderm. Several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. This will be performed by randomly assigning patients to receive either FlexHD or Alloderm. Designated outcomes will be followed closely postoperatively. Outcomes will be statistically analyzed to determine complication rates between FlexHD and Alloderm and thus which product is better to use in breast reconstruction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No Prior Breast Radiation
- •No Prior Breast Reduction
- •No Diabetes Mellitus (IDDM and non-IDDM)
- •Non-smoker or quit >6 weeks prior
- •No breast implants or prior breast implants
- •No inflammatory or autoimmune disorders
- •No current anticoagulation therapy
- •No current pregnant
排除标准
- •BMI > 30
- •Prior Breast Radiation
- •Diabetes Mellitus - IDDM and non IDDM
- •Prior Breast Reduction
- •Active Smoker or Recently Quit <6 weeks
- •Prior Breast Implants
- •Inflammatory/Autoimmune Condition (ex. Lupus)
- •Current Anticoagulation Therapy
- •Pregnancy
研究组 & 干预措施
FlexHD
Patients randomly assigned to receive FlexHD for breast reconstruction.
干预措施: FlexHD (Biological)
Alloderm
Patients randomly assigned to receive Alloderm for breast reconstruction.
干预措施: Alloderm (Biological)
结局指标
主要结局
Wound Dehiscence
时间窗: One Year
time frame.
次要结局
未报告次要终点