Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

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

Trial Details

NCT ID
NCT05190978
Phase
NA
Sponsor
University of California, Los Angeles
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Acellular Dermal Matrix
  • Reconstruction without ADM
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
  • Prophylactic and oncologic mastectomies are both acceptable
  • Nipple sparing and skin sparing mastectomy techniques are both acceptable

For full eligibility, visit ClinicalTrials.gov.

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