RecruitingNot ApplicableNCT05190978

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction


Sponsor

University of California, Los Angeles

Enrollment

120 participants

Start Date

Oct 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.


Eligibility

Sex: FEMALEMin Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a surgical mesh during pre-pectoral breast reconstruction (implant placed in front of the chest muscle after mastectomy) offers any benefit compared to reconstruction without mesh. The goal is to determine the best technique for this increasingly common procedure. **You may be eligible if...** - You are a woman between 22 and 75 years old - You are having a single or double mastectomy with immediate breast reconstruction using tissue expanders placed in front of the chest muscle (pre-pectoral) - Both preventive and cancer-related mastectomies are accepted - Nipple-sparing and skin-sparing techniques are both accepted **You may NOT be eligible if...** - Your surgeon finds the mastectomy skin flaps are too thin or unhealthy for immediate pre-pectoral reconstruction during surgery - You are having one breast reconstructed in front of the muscle and the other behind it - You are having a direct-to-implant reconstruction (skipping tissue expanders) - You are pregnant - You are having delayed reconstruction Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAcellular Dermal Matrix

Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.

PROCEDUREReconstruction without ADM

Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.


Locations(1)

University of California Los Angeles

Los Angeles, California, United States

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NCT05190978


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