Actively Recruiting
Observational Study Evaluating Safety of Acellular Dermal Matrix Processed by Supercritical CO2 Technology in Breast Reconstruction With Implants
Led by DOF Inc. · Updated on 2026-04-28
120
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a new type of acellular dermal matrix (ADM) processed using carbon dioxide supercritical fluid technology in women undergoing breast reconstruction surgery with implants after breast cancer. The study compares this new ADM product, SC Derm Recon, with other ADM products from different companies that have been cleaned with detergents. The goal is to see if the new ADM results in fewer short-term major complications following surgery. The study involves two groups: a test group of 60 women who will receive breast reconstruction surgery using the SC Derm Recon ADM processed by supercritical fluid technology, and a control group of 60 women selected retrospectively from medical records who underwent similar surgery using ADM processed with detergents. After surgery, patients in the test group will be followed up at 2, 4, and 12 weeks to monitor outcomes. Participants will be assessed for major short-term complications over the 12 weeks following their breast reconstruction surgery. Researchers will collect data from medical records for the control group and conduct follow-ups for the prospective test group. The primary measurement is the incidence rate of these complications. The study is observational and will track safety outcomes without altering standard care, with total participation lasting about 12 weeks post-operation.
CONDITIONS
Brief Title
Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 19 to 79 years
- Undergoing implant-based breast reconstruction using SC DERM® Recon after mastectomy due to breast cancer
- Willing and able to provide written informed consent and comply with study procedures and visits
- Patients who underwent implant-based breast reconstruction using acellular dermal matrix following mastectomy due to breast cancer with available medical records between March 1, 2021, and March 31, 2024
You will not qualify if you...
- Patients deemed inappropriate for participation by the investigators (such as inability to undergo required assessments)
- Patients with no recorded follow-up visits after acellular dermal matrix application
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants in the test group undergo implant-based breast reconstruction surgery using SC Derm Recon, an acellular dermal matrix processed by supercritical CO2 technology. Participants in the control group are retrospectively selected based on prior surgeries using other ADM products.
1 visit (in-person)
Duration - 12 weeks
Participants are followed up to monitor safety and complications after surgery.
Visits at 2 weeks, 4 weeks, and 12 weeks post-surgery
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Actively Recruiting
Research Team
K
kiyong Hong, Ph.D
H
Hyejin Ryu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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