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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
- Absorbable Antibacterial Matrix (device)
Sponsor: Melodi Health, Inc. · Participants: 702 · Started: Aug 9, 2024
Contact the study team
- Michele Hilmer · Phone: 210-279-0194
Official record on ClinicalTrials.gov — NCT06027996
Locations in the U.S.
| California | Stanford University, Palo Alto |
| Michigan | University of Michigan Health, Ann Arbor |
| Minnesota | Mayo Clinic, Rochester |
| New York | Northwell Health, Staten Island |
| Ohio | The Ohio State University, Columbus |
| Pennsylvania | UPMC, Pittsburgh |
| South Carolina | Medical University of South Carolina, Charleston |
| South Dakota | Monument Health, Rapid City |
| Texas | MD Anderson Cancer Center, Houston |
| Utah | University 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.