Clinical trial · Observational
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
- 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)
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM). The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.
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 |
|---|---|---|---|
| Transplant acellular dermal matrix(ADM) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Test Group
- description
- Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology).
- interventionNames
- Biological: Transplant acellular dermal matrix(ADM)
- label
- Control Group
- description
- The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022. Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study. For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study.
- interventionNames
- Biological: Transplant acellular dermal matrix(ADM)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 20 to 69 scheduled for total mastectomy * Patients who are willing to undergo immediate breast reconstruction using implants. Exclusion Criteria: * Patients who have undergone organ transplantation and are currently taking immunosuppressive medication. * Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse. * Patients who have participated in another clinical trial within 120 days prior to screening. * Any other cases where the investigator deems the patient unsuitable for this clinical study.
References
Publications (0)
Data not yet available