Breast Reconstruction
Conditions
Brief summary
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Interventions
DEVICEAcellular Dermal Matrix (Cortiva Tissue Matrix)
non-crosslinked dermis
Sponsors
RTI Surgical
MCRA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Investigational device related adverse events | 3 months, 1 year and 2 years | Rate of investigational device-related adverse events requiring additional treatment |
| Histopathology assessment | stage 2 procedure | Histopathology assessment at stage 2 procedure |
Countries
United States
Contacts
CONTACTAna Villagomez
CONTACTPaul Bonvallet, PhD
Outcome results
None listed