Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

NCT ID: NCT05190978

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2026-04-30

Brief 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.

Detailed Description

One in eight women will develop breast cancer in her lifetime, causing both physical and psychological trauma due to invasive treatments and the distress associated with removal of a breast. Breast reconstruction after mastectomy has become a critical procedure for many women to restore psychological wellbeing, with implant-based reconstruction the most common approach. Nearly 100,000 patients undergo reconstruction with implants every year in the United States.

Surgical mesh devices, particularly acellular dermal matrices, are now used off-label by most reconstructive surgeons performing prosthetic breast reconstruction. In the past decade, surgeons have advocated a transition from submuscular reconstruction (placement of the implant under the pectoralis muscle) to pre-pectoral (placement above the pectoralis) and often consider mesh to be necessary for this procedure. Surgical mesh has not been approved by the FDA for breast reconstruction for either anatomic location. These mesh devices are considered Class III medical devices and FDA recently prioritized the evaluation of these products during a panel meeting in 2019.

No Level I randomized trial has been successfully performed to determine the actual risks and benefits of mesh devices in breast reconstruction. This study proposes a pilot study as the first ever randomized, multi-center trial for mesh assistance in two-stage prosthetic pre-pectoral breast reconstruction, across the major manufacturers. The goals are to demonstrate feasibility of such a study and to generate high level data toward the evaluation of safety and effectiveness of these products for the benefit of women's public health

Conditions

Breast Cancer; Breast Implant; Complications, Infection or Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Acellular Dermal Matrix

Patients will receive ADM during their initial tissue expander placement.

Group Type: EXPERIMENTAL

Acellular Dermal Matrix

Intervention Type: DEVICE

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

Control

Patients will not receive ADM during their initial tissue expander placement.

Group Type: ACTIVE_COMPARATOR

Reconstruction without ADM

Intervention Type: PROCEDURE

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

Interventions

Acellular Dermal Matrix

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

Intervention Type: DEVICE

Reconstruction without ADM

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Michael R. Delong

Assistant Professor-in-Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Delong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Delong, MD

Role: CONTACT

mdelong@mednet.ucla.edu

(310) 825-5510

Jaco Festekjian, MD

Role: CONTACT

(310) 825-5510

Facility Contacts

Michael Delong, MD

Role: primary

mdelong@Mednet.ucla.edu

310 825 5510

Jaco Festekjian, MD

Role: backup

310 825 5510

Other Identifiers

190311

Identifier Type: -

Identifier Source: org_study_id