NCT06027996 · Melodi Health, Inc.
Melodi Matrix™ in Breast Reconstruction
What this study is about
forward-looking, conducted at multiple hospitals, randomly assigned, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
View original scientific description
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Palo Alto, California
- Ann Arbor, Michigan
- Rochester, Minnesota
- Staten Island, New York
- Columbus, Ohio
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Rapid City, South Dakota
- Houston, Texas
- Salt Lake City, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 8, 2025 · Source of record for eligibility and locations