Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Recruiting · NCT06555614 · Observational (researchers observe without assigning treatment) · Lead sponsor: DOF Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Acellular Dermal Matrix(ADM)
What this trial is about
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.
Who can take part
Age range
19 Years to 79 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, Seoul, South Korea