Clinical trial · Observational
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acellular Dermal Matrix(ADM) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Test Group
- description
- A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology.
- interventionNames
- Other: Acellular Dermal Matrix(ADM)
- label
- Control Group
- description
- A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents.
- interventionNames
- Other: Acellular Dermal Matrix(ADM)
Primary outcomes (1)
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available