RECRUITING

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

Quick Facts

Study Start:2022-10-20
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05190978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
  2. * Prophylactic and oncologic mastectomies are both acceptable
  3. * Nipple sparing and skin sparing mastectomy techniques are both acceptable
  1. * Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
  2. * Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
  3. * Direct-to-implant reconstruction
  4. * Pregnancy
  5. * Delayed reconstruction

Contacts and Locations

Study Contact

Michael Delong, MD
CONTACT
(310) 825-5510
mdelong@mednet.ucla.edu
Jaco Festekjian, MD
CONTACT
(310) 825-5510

Principal Investigator

Michael Delong, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

University of California Los Angeles
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-20
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-10-20
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • breast reconstruction
  • breast implant

Additional Relevant MeSH Terms

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