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Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Sponsor: University of California, Los Angeles
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.
Key Details
Gender
FEMALE
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2022-10-20
Completion Date
2026-04-30
Last Updated
2025-03-25
Healthy Volunteers
No
Interventions
Acellular Dermal Matrix
Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
Reconstruction 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