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Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

NCT05190978 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Acellular Dermal Matrix

Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.

PROCEDURE

Reconstruction without ADM

Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

Sponsors & Collaborators

Principal Investigators

  • Michael Delong, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-20
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05190978 on ClinicalTrials.gov