Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 22
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California Los Angeles
RECRUITING
Los Angeles
Contact Information
Primary
Michael Delong, MD
mdelong@mednet.ucla.edu
(310) 825-5510
Backup
Jaco Festekjian, MD
(310) 825-5510
Time Frame
Start Date: 2022-10-20
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Weill Medical College of Cornell University, Yale University, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, University of Utah, University of California, Davis, University of California, San Francisco
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov