Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
NCT05190978
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
- Breast Implant; Complications, Infection or Inflammation
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 22 to 75 years
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- University of California, Los Angeles
- Last updated on ClinicalTrials.gov
- May 5, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 1
- University of California Los Angeles · Los Angeles, CA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.