Evaluating the safety of a new acellular dermal matrix 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
This study is testing a new type of material used in breast reconstruction surgery to see if it causes fewer complications for women with breast cancer compared to older materials.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | Female |
| Sponsor | DOF Inc. Industry-sponsored |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06555614 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of an acellular dermal matrix (ADM) processed using CO2 supercritical fluid technology in breast reconstruction surgeries for women with breast cancer. The study will involve 120 participants, with 60 receiving the new ADM during surgery and 60 being retrospectively selected from medical records of patients who used other ADM products. Follow-up evaluations will occur at 2, 4, and 12 weeks post-surgery to monitor for complications. The primary objective is to determine if the new ADM results in fewer short-term major complications compared to traditional ADM products.
Who should consider this trial
Good fit: Ideal candidates include adult women aged 19 to 79 who are undergoing breast reconstruction surgery with implants following a mastectomy due to breast cancer.
Not a fit: Patients who are not undergoing breast reconstruction surgery or those deemed inappropriate for study participation by the investigators will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer breast reconstruction options for women undergoing surgery after breast cancer.
How similar studies have performed: While this approach is novel in its specific methodology, similar studies evaluating ADM safety have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Seoul
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Kiyong Hong, Ph.D — Seoul National University Hospital
- Study coordinator: kiyong Hong, Ph.D
- Email: kyhong@snu.ac.kr
- Phone: +82 02-2072-0310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.