Acellular Dermal Matrix Investigation in Breast Reconstruction
- Conditions
- Breast Reconstruction
- Interventions
- Device: Acellular Dermal Matrix (Cortiva Tissue Matrix)
- Registration Number
- NCT06456554
- Lead Sponsor
- RTI Surgical
- Brief Summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 467
- 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
- 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
- Is scheduled to undergo post-operative radiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Acellular Dermal Matrix Acellular Dermal Matrix (Cortiva Tissue Matrix) Breast reconstruction with Cortiva Tissue Matrix
- Primary Outcome Measures
Name Time Method Health related quality of life 12 months Change from baseline in quality of life as measured by the BREAST-Q Physical Well-Being
Rate of major adverse events 12 months Surgery-related adverse events requiring rehospitalization or reoperation of the breast under study
- Secondary Outcome Measures
Name Time Method Histopathology assessment stage 2 procedure Histopathology assessment at stage 2 procedure
Investigational device related adverse events 3 months, 1 year and 2 years Rate of investigational device-related adverse events requiring additional treatment
Change in quality of life 1 year and 2 years Change from baseline in quality of life as measured by the BREAST-Q
Procedure related adverse events 3 months, 1 year and 2 years Rate of procedure-related adverse events requiring additional treatment
Trial Locations
- Locations (6)
University of Colorado
🇺🇸Aurora, Colorado, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States