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Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Sponsor: DOF Inc.
Summary
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.
Official title: Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
Key Details
Gender
FEMALE
Age Range
19 Years - 79 Years
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2024-06-13
Completion Date
2027-02-28
Last Updated
2024-08-15
Healthy Volunteers
No
Interventions
Acellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Locations (1)
Seoul National University Hospital
Seoul, South Korea