Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Centre Hospitalier Universitaire Vaudois121 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

121

Conditions

Implants, Breast

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

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