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Melodi Matrix™ in Breast Reconstruction Study

This study is looking at the safety and effectiveness of a device called Melodi Matrix™ for women undergoing breast reconstruction after a mastectomy. The Melodi Matrix™ is an absorbable (dissolving) support coated with antibiotics. You may be able to join if you are a woman, age 22 or older, and are scheduled to have a mastectomy (removal of breast tissue) followed by a two-stage breast reconstruction. The main goal of the study is to see if using the Melodi Matrix™ helps reduce complications (problems) from breast reconstruction, which will be checked at 6 months. The study is currently unclear about its recruitment status.

Study design
This is a prospective, multicenter, randomized, controlled study. It plans to include 702 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for complications of breast reconstruction for 6 months.

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NCT06027996

Melodi Matrix™ in Breast Reconstruction

Recruiting
NAAges 22+InterventionalSupportive care
Melodi Health, Inc.
~702 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Absorbable Antibacterial Matrix

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complications of Breast Reconstruction
Measured over 6 months

Conditions

Breast Reconstruction

Explore related trials

Mammoplasty

Where it's being run

10 sites across 10 states
California1
Michigan1
Minnesota1
New York1
Ohio1
Pennsylvania1
South Carolina1
South Dakota1

Who to contact

Michele Hilmer
[email protected]
210-279-0194
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Complications of Breast Reconstruction6 months

    Key local complications