Sonication of Explanted Breast Implants for Detection of Subclinical Infection
Completed
- Conditions
- Implants, Breast
- Registration Number
- NCT01138891
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method