Breast ReconstructionNCT06027996
Melodi Matrix™ in Breast Reconstruction
A study testing Absorbable Antibacterial Matrix in people with Breast Reconstruction, run by Melodi Health, Inc. at 10 sites in United States.
Trial summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction. Read more about this study
- Who is it for?
- Ages 22 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- Absorbable Antibacterial Matrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 10 sitesUnited States
- Study dates
- 9 Aug 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
University of Michigan Health
Ann Arbor, Michigan, 48109
Jenni Hamill, 507-559-7912, jenberry@umich.edu
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Deanna DeHoff, 843-792-8522, dehoff@musc.edu
- Recruiting
The Ohio State University
Columbus, Ohio, 43212
Jenna King, 614-293-7551, cody11@osumc.edu
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Sara Hull, 832-499-6321, sehull@mdanderson.org
- Recruiting
Stanford University
Palo Alto, California, 94304
Elizabeth Tadevosyan, 818-269-1950, etadyan@stanford.edu
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213
Eleanor Shirley, 412-624-2376, shirleye@upmc.edu
- Recruiting
Monument Health
Rapid City, South Dakota, 57701
Angie Dunbar, 605-755-2370, adunbar@monument.health
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Amy Holst, 507-538-4849, BMSORESEARCH@mayo.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Martin Carricaburu, 801-581-3363
- Recruiting
Northwell Health
Staten Island, New York, 10305
Shannen Ballotte, 718-226-8559, sbelotte@northwell.edu
About this study
Official title: Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
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
- Being tested
- Absorbable Antibacterial Matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable Antibacterial MatrixDevice
Also called Melodi Matrix™
Soft tissue support coated with antibiotics
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Tissue expander implantation with the Melodi Matrix Receives: Device: Absorbable Antibacterial Matrix |
| Control | No intervention | Tissue expander implantation without a matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of Breast Reconstruction
Key local complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start9 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 702 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melodi Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027996
- Sponsor's protocol ID
- 01-2023
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)
- ClinicalTrials.gov ID
- NCT06027996
- Acronym / sponsor ID
- 01-2023
- Conditions
- Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 702 participants (estimated)
- Lead sponsor
- Melodi Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Absorbable Antibacterial MatrixTissue expander implantation with the Melodi Matrix |
| Control | No intervention | –Tissue expander implantation without a matrix |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable Antibacterial MatrixAlso: Melodi Matrix™Soft tissue support coated with antibiotics | Device | Treatment |
Primary outcome
Complications of Breast Reconstruction
Time frame: 6 months
Key local complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable Antibacterial Matrix in people with Breast Reconstruction, run by Melodi Health, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Hilmer (210-279-0194, michele.hilmer@melodihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of Breast Reconstruction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.