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
This trial does not accept healthy volunteersQualifiers
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 population
Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Acellular Dermal Matrix(ADM)
Other interventionA comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Test Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
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).
Time frame
From the day of operation of breast reconstruction to 12weeks Source ClinicalTrials.gov