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临床试验/NCT00872859
NCT00872859已完成4 期

The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

University of Utah2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2008年10月最近更新:
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:

  1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction

Secondary hypotheses:

  1. 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.
  2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
  3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix

Specific aims:

  1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
  2. Compare the complication rates between the two types of acellular dermal matrix
  3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
  4. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jay Agarwal

Chief of the Division of Plastic Surgery, Associate Professor of Surgery

University of Utah

研究点 (2)

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