Melodi Matrix™ in Breast Reconstruction

Recruiting now · Not applicable

Conditions studied: Breast Reconstruction

In brief

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

Key facts

Study ID

NCT06027996

Run by

Melodi Health, Inc.

People needed

702

Starts

2024-08-09

Expected to finish

2028-06-01

Last updated by the study team

2025-12-08

Who can join

Age: 22 and older. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• Stanford University — Palo Alto, California, United States (enrolling)
• University of Michigan Health — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Northwell Health — Staten Island, New York, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Monument Health — Rapid City, South Dakota, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.