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Melodi Matrix™ in Breast Reconstruction

RecruitingNAAges 22 Years - anyFemaleMelodi Health, Inc.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Absorbable Antibacterial Matrix
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Where

10 sites
Stanford University
Palo Alto, United States
University of Michigan Health
Ann Arbor, United States
Mayo Clinic
Rochester, United States
Northwell Health
Staten Island, United States
The Ohio State University
Columbus, United States
UPMC
Pittsburgh, United States
Medical University of South Carolina
Charleston, United States
Monument Health
Rapid City, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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