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)
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