NCT01138891已完成不适用
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
研究概览
简要总结
Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology.
Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis.
Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants .
Methods: In a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. The resulting culture results are correlated with patient, surgical and implant characteristics.
详细描述
The study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or more
- •Undergoing breast implant removal for any reason at one of the participating center
- •Explantation of breast implant performed between February 2006 and March 2009
排除标准
- •Obvious contamination of the breast implant in the operating room or during transportation.
研究者
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