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Melodi Matrix™ in Breast Reconstruction

Recruiting

Absorbable Antibacterial Soft Tissue Support in Breast Reconstruction With Infection Outcomes Assessment (ARIA)

Who can join

Ages 22 and older · Women

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: Melodi Health, Inc. · Participants: 702 · Started: Aug 9, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06027996

Locations in the U.S.

CaliforniaStanford University, Palo Alto
MichiganUniversity of Michigan Health, Ann Arbor
MinnesotaMayo Clinic, Rochester
New YorkNorthwell Health, Staten Island
OhioThe Ohio State University, Columbus
PennsylvaniaUPMC, Pittsburgh
South CarolinaMedical University of South Carolina, Charleston
South DakotaMonument Health, Rapid City
TexasMD Anderson Cancer Center, Houston
UtahUniversity of Utah, Salt Lake City

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.