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临床试验/NCT00616824
NCT00616824终止4 期

The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
36
试验地点
2
主要终点
postoperative pain

研究概览

简要总结

This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.

The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.

排除标准

  • Preoperative radiation therapy
  • Autoimmune disease
  • Uncontrolled diabetes mellitus
  • Inability to comprehend or cooperate with postoperative instructions
  • Local or systemic infection
  • Have any allergies to the excipient ingredients found in the matrix
  • Pregnancy
  • Low vascularity of the surrounding tissue
  • Mechanical trauma
  • Poor nutrition
  • Poor general medical condition

结局指标

主要结局

postoperative pain

时间窗: perioperative up to 1 year

次要结局

  • Patient satisfaction(1 year)
  • complications (infection, hematoma, capsular contracture)(1 year)
  • aesthetic outcome(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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