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โ† Trials
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Ways of Retaining the Inframammary Fold in Implant-based Breast Surgery

RecruitingNAAges 18 Years - anyFemaleBranch Office of "Hadassah Medical Ltd"
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In plain words

What the trial is, and whether it could suit you

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 polytet

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * White women; * Breast cancer stage 0-II; * Indications for breast reconstruction; * Consent to participate in the study and photographic documentation. Exclusion Criteria: * Non-white women; * Breast cancer stage III-IV; * Tubular breast; * Mental and cognitive health disorders; * Failure to comply with recommendations in the postoperative period (premature physical activity, not wearing compression underwear, missing scheduled visits, refusal of photo documentation); * Patient refusal to participate in the study at any stage.
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What it tests

  • Implant-based breast reconstruction using polytetrafluoroethylene mesh
  • Implant-based breast reconstruction using Allogeneic dura mater graft
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Where

1 site
The Branch of Hadassah Medical LTD
Moscow, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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