Melodi Matrix™ in Breast Reconstruction

NCT06027996 | Recruiting DMC FDA Device

• 1 other identifier: 01-2023
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• Complications of Breast Reconstruction

  Key local complications

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Tissue expander implantation with the Melodi Matrix

Device: Absorbable Antibacterial Matrix

Control

NO INTERVENTION

Tissue expander implantation without a matrix

Interventions

Absorbable Antibacterial Matrix DEVICE

Soft tissue support coated with antibiotics

Also known as: Melodi Matrix™

Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melodi Health, Inc.: lead

Study Sites (10)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

University of Michigan Health

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Northwell Health

Staten Island, New York, 10305, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43212, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Monument Health

Rapid City, South Dakota, 57701, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Central Study Contacts

Michele Hilmer

CONTACT

210-279-0194; michele.hilmer@melodihealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: August 9, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)