Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555692
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal MatrixSC DERM Recon in Breast Reconstruction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
After Mastectomy in Breast Cancer Patients Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal MatrixSC DERM Recon in Breast Reconstruction
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCderm
Brief 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 matrixADM 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 DermInverstigational 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None