Open Actively Recruiting

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

About

Brief 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. 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
Female
Healthy Volunteers
No
Minimum Age
22 Years
Maximum Age
75 Years

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

Join this Trial

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Study Stats
Protocol No.
21-000636
Category
Surgery
Contact
MICHAEL DELONG
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05190978
For detailed technical eligibility, visit ClinicalTrials.gov.