Establishment of an algorithm to evaluate quality and function of silicone breast implants (in the context of the PIP-/Rofil-affair)
Recruiting
- Conditions
- T85.88
- Registration Number
- DRKS00004924
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Indication for exchange or removal of silicone breast implants.
Exclusion Criteria
less than 18 years old, not able to agree
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of silicone-content in blood and tissue of the breast by means of gas-chromatography (Agilent Technologies 5973 Network: GC-distinction-column Restek Rxi-5sil MS30m x 250um x0,25um) and comparison with findings in medical imaging and clinical evidence.
- Secondary Outcome Measures
Name Time Method - establishment of an algorithm to evaluate quality of silicone-breast-implants<br>- definition of a threshold value for blood-silicone-measured value<br>- testing of the options to avoid unneccessary implant-explantations