Acellular Dermal Matrix Investigation in Breast Reconstruction
NCT ID: NCT06456554
Last Updated: 2026-01-29
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
467 participants
INTERVENTIONAL
2024-11-22
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acellular Dermal Matrix
Breast reconstruction with Cortiva Tissue Matrix
Acellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis
no Acellular Dermal Matrix
Breast reconstruction only with no ADM
No interventions assigned to this group
Interventions
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Acellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis
Eligibility Criteria
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Inclusion Criteria
* Age 22 or older at time of consent
* Undergoing immediate breast reconstruction
* 2 stage breast reconstruction using pre pectoral technique
* Nipple or skin sparing mastectomy
* Willing and capable of providing informed consent
* Able to comply with study requirements
Exclusion Criteria
* Pregnant or breast feeding
* Investigator has determined tissue is unsuitable for two-stage breast reconstruction
* History of psychological characteristics that may be incompatible with the surgical procedure and the prosthesis
* Any serious and/or unstable pre-existing medical disorder or other conditions that could interfere with the subject's safety, the informed consent process, or compliance with the study protocol, in the opinion of the investigator
* Vulnerable subject populations
* Currently participating in another clinical trial that would have the potential to interfere or conflict with the treatment, follow-up, or objectives of this study
* Prior history of neoadjuvant radiotherapy to the reconstruction site or chest wall
* Active abscess or infection in the intended reconstruction site
* Residual gross tumor at the intended reconstruction site
* Active use of any tobacco/nicotine products
* Has body mass index (BMI) \>35
* Uncontrolled diabetes defined as HbA1c ≥7 within 3 months prior to stage 1 procedure
* Is currently taking medications including systemic steroids
22 Years
FEMALE
Yes
Sponsors
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MCRA
INDUSTRY
RTI Surgical
INDUSTRY
Responsible Party
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Locations
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University of Arkansas
Little Rock, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
University of Colorado
Aurora, Colorado, United States
Washington University
St Louis, Missouri, United States
Mercy Hospital
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mercy Hospital
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Shalini Shah
Role: primary
Maryann Martinovic, MD
Role: primary
Other Identifiers
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RTI-CL-5000
Identifier Type: -
Identifier Source: org_study_id
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