Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
The goal of this observational study is to examine any clinical differences in the outcomes of breast reconstruction surgeries using Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology compared to other ADM products that have been washed with detergents. The study will also assess safety outcomes.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:
• 1\. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy
Locations
Other Locations
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jinsup Um
jinsupp@amc.seoul.kr
+82 02-3010-3600
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2025-06
Participants
Target number of participants: 100
Treatments
Test Group
Fifty subjects are to be enrolled prospectively. Breast cancer patients who are willing to undergo breast reconstruction surgery based on inserting breast implants with ADM will be selected as the test group, with SC Derm(Acellular Dermal Matrix processed by CO2 supercritical fluid technology.)
Control Group
Fifty subjects are to be enrolled retrospectively from the medical records of breast cancer patients who have undergone breast reconstruction surgery based on inserting breast implants with ADM made by other companies. All breast reconstruction surgeries have operated from 1, June 2021 to 9, November 2021 at Asan medical center at Seoul, South Korea.
Related Therapeutic Areas
Sponsors
Leads: DOF Inc.