Melodi Matrix™ in Breast Reconstruction
ConditionBreast Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorMelodi Health, Inc.
About this trial
Prospective, multicenter, randomized, controlled trial evaluating the safety and effectiveness of an absorbable antibacterial matrix device in two stage prepectoral alloplastic breast reconstruction.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Absorbable Antibacterial Matrix
Treatment groups
702 Participants
are divided into 2 treatment groupsLocations
10California
Stanford University94304, Palo Alto United States
Michigan
University of Michigan Health48109, Ann Arbor United States
Minnesota
Mayo Clinic55905, Rochester United States
New York
Northwell Health10305, Staten Island United States
Sponsors and collaborators
Melodi Health, Inc.
Lead sponsor
Source ClinicalTrials.gov