Summary

Eligibility
for females ages 22-75 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Michael Delong (ucla)

Description

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.

Keywords

Breast Cancer, Breast Implant; Complications, Infection or Inflammation, breast reconstruction, breast implant, Inflammation, Acellular Dermal Matrix, Reconstruction without ADM

Eligibility

You can join if…

Open to females ages 22-75

  • 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

You CAN'T join if...

  • 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

Location

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05190978
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated