Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
702 participants
INTERVENTIONAL
2024-08-09
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment
Tissue expander implantation with the Melodi Matrix
Absorbable Antibacterial Matrix
Soft tissue support coated with antibiotics
Control
Tissue expander implantation without a matrix
No interventions assigned to this group
Interventions
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Absorbable Antibacterial Matrix
Soft tissue support coated with antibiotics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
22 Years
FEMALE
No
Sponsors
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Melodi Health, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kassandra Carrion
Role: primary
Amy Holst
Role: primary
Jenna King
Role: primary
Deanna DeHoff
Role: primary
Sara Hull
Role: primary
Martin Carricaburu
Role: primary
Other Identifiers
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01-2023
Identifier Type: -
Identifier Source: org_study_id