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.

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Key information

Conditions

Implants, Breast

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

Clinic Birshof, Münchenstein, Switzerland
Clinic Löwencenter, Luzern, Switzerland
Crossklinik im Merian Iselin Spital, Basel, Switzerland
Medical University Innsbruck
University Hospital, Basel, Switzerland

Registry information

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2010
First posted: Jun 8, 2010
Registry last updated: Jun 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.