Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction
Recruiting now · Not applicable
Conditions studied: Breast Cancer, Breast Implant; Complications, Infection or Inflammation
In brief
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 facts
- Study ID
- NCT05190978
- Run by
- University of California, Los Angeles
- People needed
- 120
- Starts
- 2022-10-20
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-05-05
Who can join
Age: 22 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
- Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
- Direct-to-implant reconstruction
- Pregnancy
- Delayed reconstruction
Where it is running
- University of California Los Angeles — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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