Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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

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Implants, Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Removed breast implants for any reason

No interventions assigned to this group

Eligibility Criteria

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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