NCT01138891
Completed
Not Applicable
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
ConditionsImplants, Breast
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Implants, Breast
- Sponsor
- Centre Hospitalier Universitaire Vaudois
- Enrollment
- 121
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Obvious contamination of the breast implant in the operating room or during transportation.
Outcomes
Primary Outcomes
Not specified
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