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NCT Number: NCT06555614

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

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.

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Key information

Conditions

Breast Cancer Female Breast Reconstruction

Age range

19 year–79 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acellular Dermal Matrix(ADM)

Other

A comparison of the short-term complications associated with acellular dermal matrix in the test group and the control group.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Hyejin Ryu

CONTACT

[email protected]

+82-10-3514-6968

kiyong Hong, Ph.D

CONTACT

[email protected]

+82 02-2072-0310

Sponsors and collaborators

Lead sponsor

DOF Inc.

Industry

Registry information

Official study title

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

Acronym: ADM

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 15, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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