Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction (SCderm)

DOF Inc.

Status: Enrolling

Conditions: Breast Reconstruction; Breast Cancer Female

Treatments: Biological: Transplant acellular dermal matrix(ADM)

Study type: Observational

Funder types: Industry

Identifiers

NCT06555692

2023-01-002

Details and patient eligibility

About

This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is to ascertain any difference in the rate of complications between the test group of undergoing breast reconstruction with SC Derm and the control group of taking breast reconstruction with other ADM products.

Full description

In South Korea, breast reconstruction surgery using implants or autologous abdominal tissue is commonly performed as the standard treatment to address the aesthetic and psychological needs of breast cancer patients who have undergone total mastectomies. In this procedure, acellular dermal matrix (ADM) is used to compensate for the skin deficit resulting from the removal of cancerous tissue. This clinical study is designed to ascertain whether there are differences in clinical efficacy, aesthetic outcomes, and safety in breast reconstruction surgery using ADM processed with supercritical carbon dioxide technology compared to other ADMs. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology). The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged 20 to 69 scheduled for total mastectomy
• Patients who are willing to undergo immediate breast reconstruction using implants.

Exclusion criteria

• Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
• Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
• Patients who have participated in another clinical trial within 120 days prior to screening.
• Any other cases where the investigator deems the patient unsuitable for this clinical study.

Trial design

120 participants in 2 patient groups

Test Group

Description:

Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology).

Treatment:

Biological: Transplant acellular dermal matrix(ADM)

Control Group

Description:

The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022. Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study. For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study.

Treatment:

Biological: Transplant acellular dermal matrix(ADM)