Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction (NCT06555614) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
South Korea120 participantsStarted 2024-06-13
Plain-language 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.
Who can participate
Age range19 Years ā 79 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Prospective Subjects (Test Group):
* Female patients aged 19 to 79 years
* Patients undergoing implant-based breast reconstruction using SC DERMĀ® 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
What they're measuring
1
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
Timeframe: From the day of operation of breast reconstruction to 12weeks