AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

RecruitingNAAges 22 Years - 75 YearsFemaleUniversity of California, Los Angeles
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion 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 Exclusion Criteria: * 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
๐Ÿ’Š

What it tests

  • Acellular Dermal Matrix
  • Reconstruction without ADM
๐Ÿ“

Where

1 site
University of California Los Angeles
Los Angeles, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy