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Clinical Trials in the USA / NCT06456554
Recruiting Not applicable

Acellular Dermal Matrix Investigation in Breast Reconstruction

NCT06456554 · tracked via the Priya Life Science USA tracker
Sponsor
RTI Surgical
Phase
Not applicable
Started
2024-11-22
Last updated
2026-04-30

Condition(s) studied

Breast Reconstruction

Investigational drug(s) / intervention(s)

Acellular Dermal Matrix (Cortiva Tissue Matrix)

Acellular Dermal Matrix (Cortiva Tissue Matrix): non-crosslinked dermis

Study summary

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)

Trial sites (13)

FacilityCityRegionStatus
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 New York New York Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Mercy Hospital Oklahoma City Oklahoma Not Yet Recruiting
Mercy Oklahoma City Oklahoma Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
MD Anderson Houston Texas Recruiting

Other trials for the same condition

Official registry record

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.

View NCT06456554 on ClinicalTrials.gov ↗ ← All trials in the USA