Evaluating a new method for breast reconstruction after cancer surgery
Prospective Observational Study to Evaluate the Effect of Supercritical Carbon Dioxide-Processed Acellular Dermal Matrix (SC Derm® Recon) in Prosthetic Breast Reconstruction
This study is testing a new method of breast reconstruction after cancer surgery to see if a special material works better than other options for women getting implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | Female |
| Sponsor | DOF Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06553859 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare clinical outcomes of breast reconstruction surgeries using a specific Acellular Dermal Matrix (ADM) processed by CO2 supercritical fluid technology against other ADM products that have been washed with detergents. The study will involve 100 participants, with 50 patients prospectively recruited for the test group and 50 patients retrospectively selected for the control group. Participants are women aged 20 to 80 who have undergone total mastectomy for breast cancer and are scheduled for immediate reconstruction using implants. The study will also assess safety outcomes associated with the use of the new ADM.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 80 who have undergone total mastectomy for breast cancer and are planning immediate breast reconstruction using implants.
Not a fit: Patients with organ transplants on immunosuppressants, those with mental health issues affecting study participation, or those who have participated in other trials recently will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and safety in breast reconstruction surgeries for cancer patients.
How similar studies have performed: While similar studies have explored ADM in breast reconstruction, this specific approach using CO2 supercritical fluid technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 20 to 80 who undergo immediate breast reconstruction using implants after taking total mastectomy Exclusion Criteria: Patients who fall into the five categories below cannot participate in this clinical study because they meet the exclusion criteria for research subjects. 1. Patients who have received an organ transplant and are taking any immunosuppressant. 2. Patients whose mental condition may affect the progress of clinical study due to alcohol or drug abuse. 3. People who are unable to complete the survey conducted in this clinical study. 4. Patients who participated in other clinical trials within the previous 120 days at the time of screening. 5. If the investigator determine for a patient not to participate this clinical study since participation of the study is not appropriate.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jinsup Um — Asan Medical Center
- Study coordinator: Jinsup Um
- Email: jinsupp@amc.seoul.kr
- Phone: +82 02-3010-3600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.