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Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

Recruitingn/aAges 19 Years - 79 YearsFemaleDOF Inc.
NCT06555614 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

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📋 Eligibility rules (as published)
Inclusion Criteria Prospective Subjects (Test Group): * Female patients aged 19 to 79 years * Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer * Patients who voluntarily provide written informed consent after receiving a full explanation of the study objectives and procedures, and who are willing and able to comply with the study protocol and scheduled visits Retrospective Medical Record Collection (Control Group): * Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital * Availability of medical records between March 1, 2021, and March 31, 2024 Exclusion Criteria Prospective Subjects (Test Group): \- Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator (e.g., inability to undergo required assessments) Retrospective Medical Record Collection (Control Group): \- Patients with no recorded follow-up visits after application of the acellular dermal matrix
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What it tests

  • Acellular Dermal Matrix(ADM)
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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