Acellular Dermal Matrix Investigation in Breast Reconstruction
Purpose
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Condition
- Breast Reconstruction
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- Female
- Accepts 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 - Is scheduled to undergo post-operative radiation therapy
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acellular Dermal Matrix |
Breast reconstruction with Cortiva Tissue Matrix |
|
|
No Intervention no Acellular Dermal Matrix |
Breast reconstruction only with no ADM |
|
Recruiting Locations
Washington University in St. Louis and nearby locations
Washington University
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
More Details
- NCT ID
- NCT06456554
- Status
- Recruiting
- Sponsor
- RTI Surgical