RecruitingNCT06555614

Evaluation of Safety of Acellular Dermal Matrix(ADM) in Breast Reconstruction

Prospective and Retrospective, Single Center, Case-control, Investigator-initiated, Observational Study to Evaluate the Safety of Acellular Dermal Matrix Processed by the Supercritical CO2 Technology in Breast Reconstruction With Implants

Sponsor

DOF Inc.

Enrollment

120 participants

Start Date

Jun 13, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Female Breast Reconstruction

Summary

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.

Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and outcomes of using a specific tissue product (SC DERM® Recon, an acellular dermal matrix) in breast reconstruction surgery after mastectomy for breast cancer. Researchers are collecting data both from new patients and from past medical records. **You may be eligible if...** - You are a woman aged 19–79 who had breast reconstruction with implants after mastectomy for breast cancer - The reconstruction used the SC DERM® Recon tissue product - You are willing to attend follow-up visits and have provided written consent **You may NOT be eligible if...** - Your doctor believes you are not suitable for study participation - You received the tissue product but have no follow-up medical records available (for the retrospective records group) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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