Actively Recruiting
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Led by University of California, Los Angeles · Updated on 2026-05-05
120
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
W
Weill Medical College of Cornell University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
- Both prophylactic and oncologic mastectomies are allowed
- Both nipple sparing and skin sparing mastectomy techniques are allowed
You will not qualify if you...
- Poor mastectomy skin flap thickness or viability making immediate pre-pectoral reconstruction unsuitable
- Patients having bilateral reconstruction with contralateral submuscular reconstruction
- Direct-to-implant reconstruction
- Pregnancy
- Delayed reconstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
M
Michael Delong, MD
CONTACT
J
Jaco Festekjian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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