Actively Recruiting
Melodi Matrix™ in Breast Reconstruction
Led by Melodi Health, Inc. · Updated on 2025-12-08
702
Participants Needed
10
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
CONDITIONS
Official Title
Melodi Matrix™ in Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 22 years or older at enrollment
- Scheduled for unilateral or bilateral mastectomy (including prophylactic) with immediate two-stage post-mastectomy alloplastic prepectoral breast reconstruction
- Able and willing to comply with study requirements and provide informed consent
You will not qualify if you...
- Prior history of neoadjuvant radiotherapy
- Prior failed tissue expansion or breast implantation at intended reconstruction site
- Active abscess or infection requiring antibiotics within 30 days
- Body Mass Index (BMI) less than 14 or greater than 40
- Pregnant, nursing, or planning pregnancy during the study
- Any connective tissue, autoimmune disorder, or rheumatoid disease
- Known allergies to study device materials
- Participation in another interventional research study that may interfere with endpoints
- Limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments preventing participation
- Medical conditions or medications increasing risk or affecting study validity
- Intraoperative assessment shows poor mastectomy skin flap thickness or viability for immediate reconstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
2
University of Michigan Health
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Northwell Health
Staten Island, New York, United States, 10305
Actively Recruiting
5
The Ohio State University
Columbus, Ohio, United States, 43212
Actively Recruiting
6
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
7
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
8
Monument Health
Rapid City, South Dakota, United States, 57701
Actively Recruiting
9
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
10
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
M
Michele Hilmer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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