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Melodi Matrix™ in Breast Reconstruction

NCT06027996 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2025-12-08

No results posted yet for this 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.

Conditions

  • Breast Reconstruction

Interventions

DEVICE

Absorbable Antibacterial Matrix

Soft tissue support coated with antibiotics

Sponsors & Collaborators

  • Melodi Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-09
Primary Completion
2027-12-31
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06027996 on ClinicalTrials.gov