Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction (ADM)

April 23, 2026 updated by: DOF Inc.

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

The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Outline:

The total number of study subjects is 120, with 60 people recruited prospectively into the test group and 60 people retrospectively into the control group.

The test group will receive SC Derm Recon(ADM processed by CO2 supercritical fluid technology) during the implant-based breast reconstruction surgery.

The control group will be retrospectively and consecutively selected from medical records of patients who underwent implant breast reconstruction using ADM from other companies between March 1, 2021, and March 31, 2024.

After surgery, patients will be followed up at 2 weeks, 4 weeks, and 12 weeks.

Primary Objectives

I. To assess whether the test group with applying the ADM processed by the supercritical fluid technology will have less short-term major complications than the control group with the ADM processed by detergents.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: kiyong Hong, Ph.D
  • Phone Number: +82 02-2072-0310
  • Email: kyhong@snu.ac.kr

Study Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female Patients who received an acellular dermal matrix during breast reconstruction surgery with implants following a mastectomy due to breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Test Group
A prospectively selected group that will receive breast reconstruction surgery with an acellular dermal matrix called "SC Derm Recon," which is processed using carbon dioxide supercritical fluid technology.
Other: Acellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.
Control Group
A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents.
Other: Acellular Dermal Matrix(ADM)
A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate(%) of Major Short-Term Complications Over 12 Weeks Post-Application of ADM
Time Frame: From the day of operation of breast reconstruction to 12weeks
The primary endpoint is to compare and evaluate the incidence rate(%) of major short-term complications over 12 weeks following the application of acellular dermal matrix (ADM).
From the day of operation of breast reconstruction to 12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DOF Inc.

Investigators

  • Principal Investigator: Kiyong Hong, Ph.D, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-01-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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