Sonication of Explanted Breast Implants for Detection of... | NCT01138891

Studies
Sonication of Explanted Breast Implants for Detection of Subclinical Infection

NCT01138891

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

121Actual

Phase

Not provided

Conditions

Implants, Breast

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Mar 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 7, 2010

First Submission Date that Met QC Criteria

Jun 7, 2010

First Posted Date

Jun 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centre Hospitalier Universitaire VaudoisOTHER

Collaborators

Name	Class
University Hospital, Basel, Switzerland	OTHER
Medical University Innsbruck	OTHER
Clinic Löwencenter, Luzern, Switzerland	UNKNOWN
Clinic Birshof, Münchenstein, Switzerland

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

121Actual

Label	Type	Description	Intervention Names
Removed breast implants for any reason

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ulrich M Rieger, MD	Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19322605	Background	Rieger UM, Pierer G, Luscher NJ, Trampuz A. Sonication of removed breast implants for improved detection of subclinical infection. Aesthetic Plast Surg. 2009 May;33(3):404-8. doi: 10.1007/s00266-009-9333-0. Epub 2009 Mar 26.
23468161	Derived	Rieger UM, Mesina J, Kalbermatten DF, Haug M, Frey HP, Pico R, Frei R, Pierer G, Luscher NJ, Trampuz A. Bacterial biofilms and capsular contracture in patients with breast implants. Br J Surg. 2013 May;100(6):768-74. doi: 10.1002/bjs.9084. Epub 2013 Mar 6.