Condition: Breast Cancer Stage I · Breast Cancer Stage II · In Situ Breast Cancer · Sponsor: Branch Office of "Hadassah Medical Ltd"
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…
This description comes directly from the study's public registry record.
Artem Mishin, MD · +7 (910) 175-98-75 · dr.mishin@mail.ru
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| The Branch of Hadassah Medical LTD | Moscow, Skolkovo Innovation Center, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06931548