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
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 69
Healthy Volunteers: f
View:
• Female patients aged 20 to 69 scheduled for total mastectomy
• Patients who are willing to undergo immediate breast reconstruction using implants.
Locations
Other Locations
Republic of Korea
Soon Chun Hyang University Hospital
RECRUITING
Seoul
Contact Information
Primary
Woojin Song
pswjsong@schmc.ac.kr
+82 02-709-9283
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 120
Treatments
Test Group
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).
Control Group
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.
Related Therapeutic Areas
Sponsors
Leads: DOF Inc.