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Sonication of Explanted Breast Implants for Detection of Subclinical Infection

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Basel, Switzerland
Medical University Innsbruck, Austria
Clinic Löwencenter, Luzern, Switzerland
Clinic Birshof, Münchenstein, Switzerland
Crossklinik im Merian Iselin Spital, Basel, Switzerland
Information provided by:
Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01138891
First received: June 7, 2010
Last updated: June 8, 2010
Last verified: June 2010
History of Changes
  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:

U.S. FDA Resources

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138891

Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University Hospital, Basel, Switzerland
Medical University Innsbruck, Austria
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:

Additional 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
Study First Received: June 7, 2010
Last Updated: June 8, 2010
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Asymptomatic Infections
Asymptomatic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013