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Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Completed
CT.gov ID
NCT01138891
Collaborator
University Hospital, Basel, Switzerland (Other), Medical University Innsbruck (Other), Clinic Löwencenter, Luzern, Switzerland (Other), Clinic Birshof, Münchenstein, Switzerland (Other), Crossklinik im Merian Iselin Spital, Basel, Switzerland (Other)
121
Enrollment
51.9
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    121 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Feb 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2009
    Actual Study Completion Date :
    Jun 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Removed breast implants for any reason

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01138891
      Other Study ID Numbers:
      • EKBB_2008
      First Posted:
      Jun 8, 2010
      Last Update Posted:
      Jun 9, 2010
      Last Verified:
      Jun 1, 2010
      Keywords provided by , ,
      Breast implants
      capsular contraction
      sonication
      biofilm
      Complications
      surgery

      Study Results

      No Results Posted as of Jun 9, 2010