Sonication of Explanted Breast Implants for Detection of Subclinical Infection
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Study Start Date:||February 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
|Removed breast implants for any reason|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138891
|Principal Investigator:||Ulrich M Rieger, MD||Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria|