Status:
COMPLETED
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Medical University Innsbruck
Conditions:
Implants, Breast
Eligibility:
All Genders
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 s...
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.
Eligibility Criteria
Inclusion
- 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
- Obvious contamination of the breast implant in the operating room or during transportation.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01138891
Start Date
February 1 2006
End Date
June 1 2010
Last Update
June 9 2010
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