Trials / Completed
CompletedNCT01138891
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (actual)
- Sponsor
- Centre Hospitalier Universitaire Vaudois · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2009-03-01
- Completion
- 2010-06-01
- First posted
- 2010-06-08
- Last updated
- 2010-06-09
Source: ClinicalTrials.gov record NCT01138891. Inclusion in this directory is not an endorsement.