Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction
Recruiting
Observational Study
Breast Cancer Female
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 19 – 79
- Sex
- Female
- Study type
- Observational
- Participants needed
- 120 (estimated)
- Sponsor
- DOF Inc. · Industry
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About This Trial
The goal of this observational study is to evaluate the safety of Acellular Dermal Matrix(ADM) processed by CO2 supercritical fluid technology against other acellular dermal matrix products from different companies that have been washed with detergents in patients undergoing breast reconstruction surgery with implants due to the breast cancer.
Trial Locations
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Eligibility Criteria
Inclusion Criteria
Prospective Subjects (Test Group):
* Female patients aged 19 to 79 years
* Patients undergoing implant-based breast reconstruction using SC DERM® Recon (an acellular dermal matrix product) following mastectomy due to breast cancer
* Patients who voluntarily provide written infor…
Contacts