Active — Not RecruitingNot Applicable

Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

South Korea120 participantsStarted 2024-01-04

Plain-language summary

This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM). The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.

Who can participate

Age range20 Years – 69 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female patients aged 20 to 69 scheduled for total mastectomy * Patients who are willing to undergo immediate breast reconstruction using implants. Exclusion Criteria: * Patients who have undergone organ transplantation and are currently taking immunosuppressive medication. * Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse. * Patients who have participated in another clinical trial within 120 days prior to screening. * Any other cases where the investigator deems the patient unsuitable for this clinical study.

What they're measuring

Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale

Timeframe: 6 months after surgery

Trial details

NCT IDNCT06555692

SponsorDOF Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Breast Cancer Female trials