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Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

RECRUITINGSponsored by DOF Inc.
Actively Recruiting
SponsorDOF Inc.
Started2024-01-04
Est. completion2025-07-31
Eligibility
Age20 Years – 69 Years
SexFEMALE
Healthy vol.Accepted

Summary

This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is to ascertain any difference in the rate of complications between the test group of undergoing breast reconstruction with SC Derm and the control group of taking breast reconstruction with other ADM products.

Eligibility

Age: 20 Years – 69 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions4

Breast CancerBreast Cancer FemaleBreast ReconstructionCancer

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