Melodi Matrix™ in Breast Reconstruction

Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: Absorbable Antibacterial Matrix

• Study Type: Interventional
• Enrollment (Estimated): 702
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele Hilmer; Phone Number: 210-279-0194; Email: michele.hilmer@melodihealth.com

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Elizabeth Tadevosyan; Phone Number: 818-269-1950; Email: etadyan@stanford.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health
      • Contact: Jenni Hamill; Phone Number: 507-559-7912; Email: jenberry@umich.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Amy Holst; Phone Number: 507-538-4849; Email: BMSORESEARCH@mayo.edu
  • New York
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Northwell Health
      • Contact: Shannen Ballotte; Phone Number: 718-226-8559; Email: sbelotte@northwell.edu
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • The Ohio State University
      • Contact: Jenna King; Phone Number: 614-293-7551; Email: cody11@osumc.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC
      • Contact: Eleanor Shirley; Phone Number: 412-624-2376; Email: shirleye@upmc.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Deanna DeHoff; Phone Number: 843-792-8522; Email: dehoff@musc.edu
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Recruiting
      • Monument Health
      • Contact: Angie Dunbar; Phone Number: 605-755-2370; Email: adunbar@monument.health
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Sara Hull; Phone Number: 832-499-6321; Email: sehull@mdanderson.org
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Martin Carricaburu; Phone Number: 801-581-3363

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Female.
• Age 22 or older at the time of enrollment.
• Is scheduled to undergo unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction.
• Is able to and willing to comply with the study requirements and providing informed consent.

Exclusion Criteria:

• Has prior history of neoadjuvant radiotherapy.
• Has had prior history of failed tissue expansion or breast implantation at the intended reconstruction site.
• Has an active abscess or infection requiring antibiotics anywhere in their body within 30 days.
• Has a Body Mass Index (BMI) < 14 or > 40.
• Is pregnant or is nursing; or plans to become pregnant during the course of the study.
• Has any connective tissue/autoimmune disorder or rheumatoid disease.
• Has known allergies to study device materials.
• Is participating in another interventional research study that may interfere with study endpoints.
• Has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that precludes participation.
• Has a medical condition or is taking medications that would result in elevated risk and/or affect the validity of the study.
• Intraoperative assessment demonstrates unfavorable conditions (i.e., poor mastectomy skin flap thickness or viability) for immediate, two-stage post-mastectomy alloplastic prepectoral reconstruction in any breast.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Tissue expander implantation with the Melodi Matrix	Device: Absorbable Antibacterial Matrix; Soft tissue support coated with antibiotics; Other Names: Melodi Matrix™
No Intervention: Control; Tissue expander implantation without a matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications of Breast Reconstruction	Key local complications	6 months

Collaborators and Investigators

• Sponsor: Melodi Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes