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

Launched by DOF INC. · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a product called SC DERM® Recon, which is a special type of material used in breast reconstruction surgery after a mastectomy (surgery to remove a breast due to cancer). The researchers want to find out if there are any differences in complications (like infections or healing problems) between patients using SC DERM and those using other similar products. The trial is open to female patients aged 20 to 69 who are scheduled to have a total mastectomy and are willing to have immediate breast reconstruction with implants.

If you decide to participate, you will be part of a study that includes up to 120 participants at different locations. It’s important to know that certain individuals may not be eligible, such as those who have had an organ transplant or are taking medications that suppress the immune system, as well as those with certain mental health conditions. The trial is currently recruiting patients, so if you meet the criteria and are interested, you could help researchers learn more about breast reconstruction options.

Gender

FEMALE

Eligibility 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.