Evaluating the safety of a new acellular dermal matrix in breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.