Acellular Dermal Matrix Investigation in Breast Reconstruction
Recruiting now · Not applicable
Conditions studied: Breast Reconstruction
In brief
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Key facts
- Study ID
- NCT06456554
- Run by
- RTI Surgical
- People needed
- 467
- Starts
- 2024-11-22
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-30
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MD Anderson — Houston, Texas, United States (enrolling)
- City of Hope National Medical Center — Duarte, California, United States (enrolling)
- University of Colorado — Aurora, Colorado, United States (enrolling)
- University of Kansas — Lawrence, Kansas, United States (enrolling)
- Washington University — St Louis, Missouri, United States (enrolling)
- Mercy Hospital — St Louis, Missouri, United States (enrolling)
- NYU Langone Health — New York, New York, United States (enrolling)
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- University of Arkansas — Little Rock, Arkansas, United States (enrolling)
- Mercy — Oklahoma City, Oklahoma, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Mercy Hospital — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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