Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acellular Dermal Matrix(ADM).
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Breast Reconstruction. Basic parameters: 19 years — 79 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants
Overview
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.
Detailed description
Outline:
The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.
The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.
The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.
After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.
Primary Objectives
I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.
Interventions
- Other Acellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Primary outcome measures
- Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM [Time frame: From the day of operation of breast reconstruction to 12weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06555614 · 2023-01-005