Implants, BreastNCT01138891
Sonication of Explanted Breast Implants for Detection of Subclinical Infection
An observational study of Implants, Breast, run by Centre Hospitalier Universitaire Vaudois.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implants, Breast
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).
Who may be able to join
- 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
Who cannot join
- Obvious contamination of the breast implant in the operating room or during transportation.
About this study
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.
Read the 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.
- Conditions
- Implants, Breast
- Keywords
- Breast implants, capsular contraction, sonication, biofilm, Complications, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Removed breast implants for any reason | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Implants, BreastStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Medical University Innsbruck, Clinic Löwencenter, Luzern, Switzerland, Clinic Birshof, Münchenstein, Switzerland, Crossklinik im Merian Iselin Spital, Basel, Switzerland
- Investigators
- Ulrich M Rieger, MD, Principal investigator, Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138891
- Sponsor's protocol ID
- EKBB_2008
- Status last verified
- Jun 2010
- First submitted
- 7 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19322605Rieger 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.
PubMed 23468161
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonication of Explanted Breast Implants for Detection of Subclinical Infection
- ClinicalTrials.gov ID
- NCT01138891
- Acronym / sponsor ID
- EKBB_2008
- Conditions
- Implants, Breast
- Keywords
- Breast implants, capsular contraction, sonication, biofilm, Complications, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Medical University Innsbruck, Clinic Löwencenter, Luzern, Switzerland, Clinic Birshof, Münchenstein, Switzerland, Crossklinik im Merian Iselin Spital, Basel, Switzerland
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Removed breast implants for any reason | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Five plastic surgery clinics in Switzerland participated in this study (Basel, Luzern, Dornach, Lausanne, Münchenstein).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Obvious contamination of the breast implant in the operating room or during transportation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
- Background: PubMed 19322605Rieger 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.
- Derived from this study: PubMed 23468161Rieger 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.
Related trials for Implants, Breast
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich M Rieger, MD principal investigator
Department of Plastic, Reconstructive & Aesthetic Surgery, Medical University, Innsbruck, Austria
Questions about this trial
What is this clinical trial studying?
An observational study of Implants, Breast, run by Centre Hospitalier Universitaire Vaudois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.