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Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
Sponsor: DOF Inc.
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.
Official title: After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
Key Details
Gender
FEMALE
Age Range
20 Years - 69 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-01-04
Completion Date
2026-09-30
Last Updated
2026-04-28
Healthy Volunteers
No
Interventions
Transplant acellular dermal matrix(ADM)
The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation.
Locations (1)
Soon Chun Hyang University Hospital
Seoul, Seoul, South Korea