Sonication of Explanted Breast Implants for Detection of Subclinical Infection

June 8, 2010 updated by: Centre Hospitalier Universitaire Vaudois

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 Overview

Status

Completed

Conditions

Detailed Description

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 (Actual)

121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Removed breast implants for any reason

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

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

Investigators

  • Principal Investigator: Ulrich M Rieger, MD, Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (Estimate)

June 8, 2010

Study Record Updates

Last Update Posted (Estimate)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKBB_2008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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