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

DOF Inc.

Status: Enrolling

Conditions: Breast Reconstruction; Breast Cancer Female

Treatments: Other: Acellular Dermal Matrix(ADM)

Study type: Observational

Funder types: Industry

Identifiers

NCT06555614

2023-01-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Prospective subjects (Test group) 1) Adult women aged 19 to 79 years. 2) Patients who received SC DERM® Recon, an acellular dermal matrix product, during breast reconstruction surgery with implants following a mastectomy due to breast cancer. 3) Individuals who have voluntarily provided written informed consent after receiving an explanation of the study's purpose and methods, are willing to comply with the study protocol, and are willing to visit the hospital for the evaluation of observational parameters.
2. Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product during breast reconstruction surgery with implants following a mastectomy due to breast cancer at Seoul National University Hospital between March 1, 2021, and March 31, 2024.

Exclusion criteria

1. Prospective subjects (Test group) 1) Individuals deemed inappropriate for study participation by the principal investigator or other investigator's judgement. (e.g., those unable to undergo the required tests for this study).
2. Retrospective Medical Record Collection 1) Patients who received an acellular dermal matrix product but have no recorded follow-up visits after application.

Trial design

120 participants in 2 patient groups

Test Group

Description:

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.

Treatment:

Other: Acellular Dermal Matrix(ADM)

Control Group

Description:

A retrospectively selected group that has undergone breast reconstruction surgery with an acellular dermal matrix processed using chemical detergents.

Treatment:

Other: Acellular Dermal Matrix(ADM)