Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Implant; Complications, Infection or Inflammation
• Intervention / Treatment: Device: Acellular Dermal Matrix; Procedure: Reconstruction without ADM

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Delong, MD; Phone Number: (310) 825-5510; Email: mdelong@mednet.ucla.edu
• Study Contact Backup: Name: Jaco Festekjian, MD; Phone Number: (310) 825-5510

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
      • Contact: Jaco Festekjian, MD; Phone Number: 310 825 5510
      • Principal Investigator: Michael DeLong, MD
      • Principal Investigator: Jaco Festekjian, MD
      • Sub-Investigator: Ginger Slack, MD
      • Contact: Michael Delong, MD; Phone Number: 310 825 5510; Email: mdelong@Mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acellular Dermal Matrix; Patients will receive ADM during their initial tissue expander placement.	Device: Acellular Dermal Matrix; Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.
Active Comparator: Control; Patients will not receive ADM during their initial tissue expander placement.	Procedure: Reconstruction without ADM; Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety - Major Complications	Relative rate of major complications (requiring unplanned re-admission or re-operation)	2 years
Effectiveness - BREASTQ	BREAST-Q validated patient reported questionnaire to assess results of final reconstruction.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness	Time from expander placement to implant exchange	2 years
Secondary Safety	Individual complication rates	2 years
Capsular Contracture	Rate of capsular contracture	2 years

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Yale University; Weill Medical College of Cornell University; University of California, Davis; University of California, San Francisco; University of Utah
• Investigators: Principal Investigator: Michael Delong, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; breast reconstruction; breast implant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Inflammation; Infections; Surgical Procedures, Operative; Plastic Surgery Procedures
• Other Study ID Numbers: 190311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All our results will be published in peer-reviewed journals in a timely manner for reference by physicians, manufacturers, regulatory agencies, and patients. As part of the study consent, subjects will be asked whether they agree to share their data in de-identified format with researchers. Data privacy and protection is a top priority. All data made available for public use will be de-identified, i.e., stripped of personally identifiable information (pii) and personal health information (phi) that could be used to deduce the identity of individual subjects, according to the HIPAA Privacy Rule, to comply with the NIH Privacy Rule and Research guidance

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No