Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
DOF Inc.
100 participants
Jun 12, 2023
OBSERVATIONAL
Conditions
Summary
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.
Eligibility
Inclusion Criteria1
- \. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
Exclusion Criteria5
- Patients who have received an organ transplant and are taking any immunosuppressant.
- Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse.
- People who are unable to complete the survey conducted in this clinical study.
- Patients who participated in other clinical trials within the previous 120 days at the time of screening.
- If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
Interventions
The type and method of breast reconstruction with sillicon implants and ADM implanting is now the standard treatment of breast cancer in korea. no any specific intervention has occurred during the surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06553859