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

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

NCT ID: NCT06555692

Condition: Breast Cancer Female
Breast Reconstruction

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Acellular Dermal Matrix(ADM)
Breast Reconstruction using implants and ADM

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Biological
Intervention name: Transplant acellular dermal matrix(ADM)
Description: 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.
Arm group label: Control Group
Arm group label: Test Group

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.

Criteria for eligibility:

Study pop:
Female patients who have undergone total mastectomy due to breast cancer from three primary university hospitals.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Minimum age: 20 Years

Maximum age: 69 Years

Healthy volunteers: No

Locations:

Facility:
Name: Soon Chun Hyang University Hospital

Address:
City: Seoul
Zip: 04401
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Soomin Lee
Email: 20160470@schmc.ac.kr

Investigator:
Last name: Woojin Song
Email: Principal Investigator

Investigator:
Last name: Sangkyu Kang
Email: Sub-Investigator

Start date: January 4, 2024

Completion date: December 31, 2025

Lead sponsor:
Agency: DOF Inc.
Agency class: Industry

Source: DOF Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06555692
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7225454/
https://pubmed.ncbi.nlm.nih.gov/32221196/
https://pubmed.ncbi.nlm.nih.gov/31335468/
https://pubmed.ncbi.nlm.nih.gov/32353944/
https://link.springer.com/article/10.1007/s40883-018-0080-0
https://pubmed.ncbi.nlm.nih.gov/29223704/
https://pubmed.ncbi.nlm.nih.gov/23346164/
https://pubmed.ncbi.nlm.nih.gov/28207027/
https://pubmed.ncbi.nlm.nih.gov/32158893/