Sonication of Explanted Breast Implants for Detection of Subclinical Infection
|ClinicalTrials.gov Identifier: NCT01138891|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : June 9, 2010
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||121 participants|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2010|
|Removed breast implants for any reason|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138891
|Principal Investigator:||Ulrich M Rieger, MD||Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria|