Skin sparing mastectomy with implant reconstruction: clinical outcomes and cost effectiveness of reconstruction in one stage with the use of a collagen matrix. A randomized clinical trial.
- Conditions
- Borstreconstructies.Borstkankerbreast reconstruction.10006295
- Registration Number
- NL-OMON39753
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
Female patients from the participating hospitals are included if they meet the following criteria: willing and able to participate; aged 18 and over; able to provide informed consent and to complete questionnaires. Women who meet the inclusion criteria are informed about the study by their doctor and recieve a patientletter. There will be the possibility to ask further questions. Patients are included after signing the informed consent.
Exclusion criteria are: pregnancy or planning a pregnancy during the study; ongoing severe psychiatric illness or mental retardation; evidence of alcohol and/or drug abuse; inability to complete the questionnaires; local or general infection which could jeopardize the surgical objective; extensive local inflammatory reactions; proven or suspected hypersensitivity to materials; immunosuppressive pathologies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method