Clinical trial · Observational
Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction
Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
NCT06553859CI-TRIAL-00079798SCdermunknownClinicalTrials.gov clinicaltrialsProvenance
- 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 examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention conducts. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Test Group
- description
- Fifty subjects are to be enrolled prospectively. Breast cancer patients who are willing to undergo breast reconstruction surgery based on inserting breast implants with ADM will be selected as the test group, with "SC Derm"(Acellular Dermal Matrix processed by CO2 supercritical fluid technology.)
- interventionNames
- Other: No intervention conducts.
- label
- Control Group
- description
- Fifty subjects are to be enrolled retrospectively from the medical records of breast cancer patients who have undergone breast reconstruction surgery based on inserting breast implants with ADM made by other companies. All breast reconstruction surgeries have operated from 1, June 2021 to 9, November 2021 at Asan medical center at Seoul, South Korea.
Primary outcomes (1)
- measure
- The number of occurrences of pre-determined expected adverse events and complications
- timeFrame
- From the day of operation of breast reconstruction to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy Exclusion Criteria: Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects. 1. Patients who have received an organ transplant and are taking any immunosuppressant. 2. Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse. 3. People who are unable to complete the survey conducted in this clinical study. 4. Patients who participated in other clinical trials within the previous 120 days at the time of screening. 5. If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
References
Publications (0)
Data not yet available
No reference posted for this study.