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Evaluation of ADM(SC Derm® Recon) in Breast Reconstruction

RECRUITINGSponsored by DOF Inc.
Actively Recruiting
SponsorDOF Inc.
Started2023-06-12
Est. completion2025-06
Eligibility
Age20 Years – 80 Years
SexFEMALE
Healthy vol.Accepted

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

Age: 20 Years – 80 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions3

Breast CancerBreast Cancer FemaleCancer

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