Breast Cancer Female, Breast Reconstruction
Conditions
Brief 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.
Detailed description
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.
Interventions
OTHERAcellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Sponsors
DOF Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM | From the day of operation of breast reconstruction to 12weeks | 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). |
Countries
South Korea
Contacts
CONTACTkiyong Hong, Ph.D
CONTACTHyejin Ryu
PRINCIPAL_INVESTIGATORKiyong Hong, Ph.D
Seoul National University Hospital
Outcome results
None listed