Melodi Matrix™ in Breast Reconstruction

Melodi Health, Inc.

Status

Enrolling

Conditions

Breast Reconstruction

Treatments

Device: Absorbable Antibacterial Matrix

Study type

Interventional

Funder types

Industry

Identifiers

NCT06027996

01-2023

Details and patient eligibility

About

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

Enrollment

702 estimated patients

Sex

Female

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.