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โ† Trials
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Acellular Dermal Matrix Investigation in Breast Reconstruction

RecruitingNAAges 22 Years - anyFemaleRTI Surgical
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In plain words

What the trial is, and whether it could suit you

Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Genetic female * 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: * Planned concurrent reconstruction with pedicled flaps or free tissue * 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 โ‰ฅ7 within 3 months prior to stage 1 procedure * Is currently taking medications including systemic steroids
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What it tests

  • Acellular Dermal Matrix (Cortiva Tissue Matrix)
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Where

13 sites
University of Arkansas
Little Rock, United States
City of Hope National Medical Center
Duarte, United States
University of Colorado
Aurora, United States
University of Kansas
Lawrence, United States
Washington University
St Louis, United States
Mercy Hospital
St Louis, United States
NYU Langone Health
New York, United States
New York Presbyterian Hospital/Columbia University Irving Medical Center
New York, United States

โ€ฆand 5 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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