Ireland
--:--IST
Recruiting Not applicable

Melodi Matrix™ in Breast Reconstruction

NCT06027996 · tracked via the Priya Life Science USA tracker
Sponsor
Melodi Health, Inc
Phase
Not applicable
Started
2024-08-09
Last updated
2025-12-08

Condition(s) studied

Breast Reconstruction

Investigational drug(s) / intervention(s)

Absorbable Antibacterial Matrix

Absorbable Antibacterial Matrix: Soft tissue support coated with antibiotics

Study 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

Sex
FEMALE
Min age
22 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Complications of Breast Reconstruction — 6 months
    Key local complications

Trial sites (10)

FacilityCityRegionStatus
Stanford University Palo Alto California Recruiting
University of Michigan Health Ann Arbor Michigan Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Northwell Health Staten Island New York Recruiting
The Ohio State University Columbus Ohio Recruiting
UPMC Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Monument Health Rapid City South Dakota Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06027996 on ClinicalTrials.gov ↗ ← All trials in the USA