The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women undergoing bilateral nipple or skin sparing mastectomy in a prophylactic setting followed by tissue-expander based breast reconstruction. Researchers will compare intra-individually, the conventional textured expander CPX®(Mentor) and the SmoothSilk® (Motiva) expander (i) to gain a comprehensive insight into immunological mechanisms occurring at the timepoint of expander insertion (within the first days after implantation) based on WBF analysis in vitro, (ii)to determine the role and function of immune cells in a rather early stage of capsule formation (6-8 months after implantation) and under well-defined conditions in humans as well as (iii)to analyze the aesthetic outcome and clinical parameters after bilateral implant-based reconstruction using two expanders with varying surface topography within the individual patient (intra-individually).
Age range
18 Years – 99 Years
Sex
FEMALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
wound bed fluid Immune cell profile (composition)
Timeframe: 1 to 5 days post expander implantation
wound bed fluid wound proteome composition
Timeframe: 1 to 5 days post expander implantation
wound bed fluid Immune cell activity
Timeframe: 1 to 5 days post expander implantation
wound bed fluid wound microbiome composition
Timeframe: 1 to 5 days post expander implantation