Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19-79
SponsorDOF Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Patients who underwent implant-based breast reconstruction using an acellular dermal matrix product following mastectomy due to breast cancer at Seoul National University Hospital
Disqualifiers
None
Trial design
Treatments tested in this trial
- Acellular Dermal Matrix(ADM)
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov