Recruiting

Melodi Matrix™

Sponsor:

Melodi Health, Inc.

Code:

NCT06027996

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Absorbable Antibacterial Matrix

Study Details

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

Study ID

NCT06027996

Start date

Aug 9, 2024

Status verified date

Dec, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

702 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment

Tissue expander implantation with the Melodi Matrix

no intervention: Control

Tissue expander implantation without a matrix

Interventions

Absorbable Antibacterial Matrix

Soft tissue support coated with antibiotics

Primary outcome measure

  • Complications of Breast Reconstruction [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Michele Hilmer

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

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Elizabeth Tadevosyan

818-269-1950etadyan@stanford.edu

University of Michigan Health

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jenni Hamill

507-559-7912jenberry@umich.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amy Holst

507-538-4849BMSORESEARCH@mayo.edu

Northwell Health

Recruiting

Staten Island, New York, United States, 10305

Contacts

Shannen Ballotte

718-226-8559sbelotte@northwell.edu

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Jenna King

614-293-7551cody11@osumc.edu

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Eleanor Shirley

412-624-2376shirleye@upmc.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Deanna DeHoff

843-792-8522dehoff@musc.edu

Monument Health

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

Angie Dunbar

605-755-2370adunbar@monument.health

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Sara Hull

832-499-6321sehull@mdanderson.org

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Martin Carricaburu

801-581-3363

More Information

Sponsor

Melodi Health, Inc.

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Melodi Health, Inc. on 2025-12-08.