NCT00872859已完成4 期
The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Effects of radiation on acellular dermal matrix
研究概览
简要总结
Primary Hypothesis:
- Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
Secondary hypotheses:
- The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
- Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
- Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
Specific aims:
- Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
- Compare the complication rates between the two types of acellular dermal matrix
- Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
- Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation
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
- Single (Investigator)
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
- 否
入选标准
- •Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
- •Female gender
- •Age between 18 and 80
- •Consent to participate in the study
排除标准
- •Patients not undergoing breast reconstruction following mastectomy
- •Patients undergoing delayed breast reconstruction following mastectomy
- •Patients undergoing immediate definitive breast reconstruction after mastectomy
- •Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
- •Medical debility precluding surgical treatment
- •Prior breast or chest wall irradiation
- •Pregnant patients
- •Male gender
结局指标
主要结局
Effects of radiation on acellular dermal matrix
时间窗: four years
次要结局
未报告次要终点
研究者
Jay Agarwal
Chief of the Division of Plastic Surgery, Associate Professor of Surgery
University of Utah
研究点 (2)
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