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.
Outline: The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group. The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery. The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024. After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks. Primary Objectives I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.
Study Type
OBSERVATIONAL
Enrollment
120
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Seoul National University Hospital
Seoul, Seoul, South Korea
RECRUITINGIncidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).
Time frame: From the day of operation of breast reconstruction to 12weeks
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