Evaluating a new method for breast reconstruction using acellular dermal matrix
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
This study is testing a new type of material used in breast reconstruction surgery to see if it works better and is safer than other options for women who have had a mastectomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 20 Years to 69 Years |
| Sex | Female |
| Sponsor | DOF Inc. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06555692 on ClinicalTrials.gov |
What this trial studies
This observational study involves up to 120 female patients undergoing breast reconstruction surgery after total mastectomy, comparing the effectiveness and safety of a new acellular dermal matrix (SC DERM® Recon) with other existing ADM products. The study will include a prospective group of 60 patients receiving the investigational ADM and a retrospective group of 60 patients who received other ADMs, analyzing differences in complication rates and aesthetic outcomes. The aim is to provide insights into the clinical efficacy and safety of this new approach in breast reconstruction.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 20 to 69 who are scheduled for total mastectomy and willing to undergo immediate breast reconstruction.
Not a fit: Patients with organ transplants, mental health conditions affecting study conduct, or those who have participated in another clinical trial recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for breast cancer patients undergoing reconstruction.
How similar studies have performed: While similar studies have explored the use of ADM in breast reconstruction, the specific application of supercritical carbon dioxide technology in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Soon Chun Hyang University Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Woojin Song, Ph.D — Soon Chun Hyang University
- Study coordinator: Woojin Song
- Email: pswjsong@schmc.ac.kr
- Phone: +82 02-709-9283
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.