Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05190978
Status
Recruiting
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Conditions

  • Breast Cancer
  • Breast Implant; Complications, Infection or Inflammation

Eligibility Criteria

Sex
FEMALE
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Acellular Dermal Matrix — DEVICE
    Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
  • Reconstruction without ADM — PROCEDURE
    Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

Study Details

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 Dates

Start date
Oct 20, 2022
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acellular Dermal Matrix
    Patients will receive ADM during their initial tissue expander placement.
  • Active Comparator: Control
    Patients will not receive ADM during their initial tissue expander placement.

Primary Outcome Measure

Safety - Major Complications [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90095
Michael Delong, MD
[email protected]
310 825 5510
Jaco Festekjian, MD
310 825 5510
Michael DeLong, MD (PRINCIPAL_INVESTIGATOR)
Jaco Festekjian, MD (PRINCIPAL_INVESTIGATOR)
Ginger Slack, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of California Los Angeles· Los Angeles, CA

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