Recruiting NCT06456554
Acellular Dermal Matrix Investigation in Breast Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acellular Dermal Matrix (Cortiva Tissue Matrix).
- Who it may be relevant to
- Registry conditions: Breast Reconstruction. Basic parameters: from 22 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Interventions
- Device Acellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis
Primary outcome measures
- Rate of major adverse events [Time frame: 12 months]
- Health related quality of life [Time frame: 12 months]
Secondary outcome measures (4)
- Change in quality of life [Time frame: 1 year and 2 years]
- Procedure related adverse events [Time frame: 3 months, 1 year and 2 years]
- Investigational device related adverse events [Time frame: 3 months, 1 year and 2 years]
- Histopathology assessment [Time frame: stage 2 procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- University of Arkansas — Little Rock
- City of Hope National Medical Center — Duarte
- University of Colorado — Aurora
- University of Kansas — Lawrence
- Washington University — St Louis
- Mercy Hospital — St Louis
- NYU Langone Health — New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York
- … and 5 more centers
Identifiers
NCT: NCT06456554 · RTI-CL-5000