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NCT06456554NARecruitingAccepts Healthy Volunteers

Acellular Dermal Matrix Investigation in Breast Reconstruction

RTI Surgical

Start Date

11/22/2024

Completion Date

12/1/2027

Summary

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

Eligibility Criteria

Age Range: 22 years to No maximum

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 ≥7 within 3 months prior to stage 1 procedure * Is currently taking medications including systemic steroids

Interventions

DEVICE

Acellular Dermal Matrix (Cortiva Tissue Matrix)

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Conditions

Breast Reconstruction

Locations

University of Arkansas

Little Rock, Arkansas 72205

United States

City of Hope National Medical Center

Duarte, California 91010

United States

University of Colorado

Aurora, Colorado 80045

United States

University of Kansas

Lawrence, Kansas 66045

United States

Washington University

St Louis, Missouri 63110

United States

Mercy Hospital

St Louis, Missouri 63141

United States

NYU Langone Health

New York, New York 10016

United States

New York Presbyterian Hospital/Columbia University Irving Medical Center

New York, New York 10032

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Mercy Hospital

Oklahoma City, Oklahoma 73120

United States

Mercy

Oklahoma City, Oklahoma 73120

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

MD Anderson

Houston, Texas 77030

United States