Sonication of Explanted Breast Implants for Detection of Subclinical Infection
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire Vaudois
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 7, 2010 | ||||
| Last Updated Date | June 8, 2010 | ||||
| Start Date ICMJE | February 2006 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01138891 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Sonication of Explanted Breast Implants for Detection of Subclinical Infection | ||||
| Official Title ICMJE | Not Provided | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Breast implants |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein). |
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| Condition ICMJE | Implants, Breast | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Removed breast implants for any reason | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 121 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01138891 | ||||
| Other Study ID Numbers ICMJE | EKBB_2008 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Andrej Trampuz, University Hospital Lausanne, Switzerland | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire Vaudois | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire Vaudois | ||||
| Verification Date | June 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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