Melodi Matrix™ in Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Breast Reconstruction
• Interventions: Device: Absorbable Antibacterial Matrix

• Registration Number: NCT06027996
• Lead Sponsor: Melodi Health, Inc.

Brief Summary

Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Study Start: 2024-08-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 702

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Absorbable Antibacterial Matrix	Tissue expander implantation with the Melodi Matrix

Primary Outcome Measures

Name	Time	Method
Complications of Breast Reconstruction	6 months	Key local complications

Trial Locations

Locations (6)

Stanford University; 🇺🇸 Palo Alto, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States