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Sonication of Explanted Breast Implants for Detection of Subclinical Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138891
First Posted: June 8, 2010
Last Update Posted: June 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University Hospital, Basel, Switzerland
Medical University Innsbruck
Clinic Löwencenter, Luzern, Switzerland
Clinic Birshof, Münchenstein, Switzerland
Crossklinik im Merian Iselin Spital, Basel, Switzerland
Information provided by:
Centre Hospitalier Universitaire Vaudois
  Purpose

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
Implants, Breast

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Biospecimen Retention:   Samples Without DNA
Breast implants

Enrollment: 121
Study Start Date: February 2006
Study Completion Date: June 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Removed breast implants for any reason

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138891


Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Andrej Trampuz, University Hospital Lausanne, Switzerland
ClinicalTrials.gov Identifier: NCT01138891     History of Changes
Other Study ID Numbers: EKBB_2008
First Submitted: June 7, 2010
First Posted: June 8, 2010
Last Update Posted: June 9, 2010
Last Verified: June 2010

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Breast implants
capsular contraction
sonication
biofilm
Complications
surgery