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Sonication of Explanted Breast Implants for Detection of Subclinical Infection

NCT01138891 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2010-06-09

No results posted yet for this study

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.

Conditions

  • Implants, Breast

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • Medical University Innsbruck

    collaborator OTHER

  • Clinic Löwencenter, Luzern, Switzerland

    collaborator UNKNOWN

  • Clinic Birshof, Münchenstein, Switzerland

    collaborator UNKNOWN

  • Crossklinik im Merian Iselin Spital, Basel, Switzerland

    collaborator UNKNOWN

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

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

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2009-03-31
Completion
2010-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01138891 on ClinicalTrials.gov