Randomized Feasibility Trial for Mesh in Pre-Pectoral Reconstruction

NCT05190978 | Recruiting DMC FDA Device

• 1 other identifier: 190311
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Implant; Complications, Infection or Inflammation

Keywords

breast cancer; breast reconstruction; breast implant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Secondary Effectiveness

  2 years

• Secondary Safety

  2 years

• Capsular Contracture

  2 years

Study Arms (2)

Acellular Dermal Matrix

EXPERIMENTAL

Patients will receive ADM during their initial tissue expander placement.

Device: Acellular Dermal Matrix

Control

ACTIVE COMPARATOR

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

Procedure: Reconstruction without ADM

Interventions

Acellular Dermal Matrix DEVICE

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

Acellular Dermal Matrix

Reconstruction without ADM PROCEDURE

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

Control

Eligibility Criteria

• Age: 22 Years - 75 Years
• Gender Eligibility Details: Female patients with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: collaborator
• University of California, Davis: collaborator
• University of California, Los Angeles: lead
• Yale University: collaborator
• University of Utah: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Infections; Inflammation

Interventions

Plastic Surgery Procedures

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Michael Delong, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Delong, MD

CONTACT

(310) 825-5510; mdelong@mednet.ucla.edu

Jaco Festekjian, MD

CONTACT

(310) 825-5510

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will blinded to whether they receive ADM products during their reconstruction.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-in-Residence

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 13, 2022
• Study Start: October 20, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)