NCT06555692

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

After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: DOF Inc. · Industry
• Sex: Female
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Cancer Female
• Breast Reconstruction

Interventions

Type	Name	Description
BIOLOGICAL	Transplant acellular dermal matrix(ADM)	The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation.

Timeline

• Start date: 2024-01-04
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: South Korea