Back to Trials
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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

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