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Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery

Branch Office of "Hadassah Medical Ltd" · 2022
ClinicalTrials.gov · Datasets · License: Public Domain · 2022
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breast-cancerna
There is currently no consensus on the "gold standard" for Implant-based Breast reconstruction. In the United States, more than half of all breast reconstructions are performed using acellular dermal matrix (ADM). However, based on the findings of literature and systematic reviews, it can be cautiously said that synthetic meshes cause fewer complications with comparable aesthetic results and low cost. In our study, we propose using polytetrafluoroethylene (PTFE) mesh in implant-based breast reconstruction. This material has previously proven itself in cardiovascular, maxillofacial and neurosurgery, hernioplasty and as a suture material. Allogeneic dura mater, which has demonstrated comparable results in breast reconstruction with the literature, will be used as a comparison. The purpose of this study is to evaluate the efficacy and safety of a porous, non-biodegradable, synthetic polytetrafluoroethylene mesh for implant-based breast reconstruction in patients diagnosed with breast cancer. An allogeneic dura mater technique will be used as a control. Patients eligible for this study are classified according to the National Comprehensive Cancer Network (NCCN) guidelines as having stage 0-2 breast cancer. The primary questions this study aims to answer are: * What are the rates of major and minor complications associated with these techniques. Major complications will be defined as complications leading to reoperation. * How effective are PTFE mesh and dura in maintaining the inframammary fold and implant projection after breast reconstruction? * What is the patient satisfaction rate with the surgical results? Patients will be randomly assigned to the study but will know which technique will be used in their particular case. Patients included in this study will undergo subcutaneous mastectomy or skin-sparing mastectomy using standard techniques with simultaneous implantation using PTFE mesh or allogeneic dura mater graft. In our opinion, the mesh and graft will sta
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