Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Eligibility
Sex
FEMALE
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Rate of major adverse events — 12 months Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
Health related quality of life — 12 months Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Trial sites (13)
Facility
City
Region
Status
University of Arkansas
Little Rock
Arkansas
Recruiting
City of Hope National Medical Center
Duarte
California
Recruiting
University of Colorado
Aurora
Colorado
Recruiting
University of Kansas
Lawrence
Kansas
Recruiting
Washington University
St Louis
Missouri
Recruiting
Mercy Hospital
St Louis
Missouri
Recruiting
NYU Langone Health
New York
New York
Recruiting
New York Presbyterian Hospital/Columbia University Irving Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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