NCT06027996NARecruiting
Melodi Matrix™ in Breast Reconstruction
Melodi Health, Inc.
Start Date
8/9/2024
Completion Date
6/1/2028
Summary
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility Criteria
Age Range: 22 years to No maximum
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.
Interventions
DEVICE
Absorbable Antibacterial Matrix
Conditions
Breast Reconstruction
Locations
Stanford University
Palo Alto, California 94304
United States
University of Michigan Health
Ann Arbor, Michigan 48109
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Northwell Health
Staten Island, New York 10305
United States
The Ohio State University
Columbus, Ohio 43212
United States
UPMC
Pittsburgh, Pennsylvania 15213
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Monument Health
Rapid City, South Dakota 57701
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84112
United States