🏛️ Verified NIH Record • Updated 2026-04-29
Acellular Dermal Matrix Investigation in Breast Reconstruction (NCT06456554)
🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: RTI Surgical
🩺 Plain-English Summary (8th-Grade Level)
Prospective, multi-center, dual-arm non-randomized clinical study in females undergoing a two-stage breast reconstruction using a pre-pectoral technique.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (15 items).
Location: University of Arkansas — Little Rock, Arkansas
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- University of Arkansas — Little Rock, Arkansas
- City of Hope National Medical Center — Duarte, California
- University of Colorado — Aurora, Colorado
- University of Kansas — Lawrence, Kansas
- Washington University — St Louis, Missouri
- Mercy Hospital — St Louis, Missouri
- NYU Langone Health — New York, New York
- New York Presbyterian Hospital/Columbia University Irving Medical Center — New York, New York
- Cleveland Clinic — Cleveland, Ohio
- Mercy Hospital — Oklahoma City, Oklahoma
- Mercy — Oklahoma City, Oklahoma
- University of Pennsylvania — Philadelphia, Pennsylvania
- MD Anderson — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.