🏛️ Verified NIH Record • Updated 2026-02-20

Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns (NCT04090424)

A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: PolyNovo Biomaterials Pty Ltd.

🩺 Plain-English Summary (8th-Grade Level)

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).

Who can join: Review the eligibility criteria below.

Location: Valleywise Health — Phoenix, Arizona

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • Valleywise Health — Phoenix, Arizona
  • Southern California Regional Burn Center at LAC+USC — Los Angeles, California
  • University of California Davis Medical Center — Sacramento, California
  • Bridgeport Hospital — Bridgeport, Connecticut
  • MedStar Washington Hospital Center — Washington D.C., District of Columbia
  • Tampa General Hospital — Tampa, Florida
  • Emory University at Grady Memorial Hospital — Atlanta, Georgia
  • Loyola University of Chicago — Maywood, Illinois
  • University of Iowa Hospital and Clinics — Iowa City, Iowa
  • University of Kansas Hospital — Kansas City, Kansas
  • University Medical Center, New Orleans — New Orleans, Louisiana
  • Brigham and Women's Hospital — Boston, Massachusetts
  • Massachusetts General Hospital — Boston, Massachusetts
  • New York Presbyterian Weill Cornell Medicine — New York, New York
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
  • Wake Forest Baptist Health — Winston-Salem, North Carolina
  • Akron Children's Hospital, Burn Center — Akron, Ohio
  • The Ohio State University/ Wexner Medical Center — Columbus, Ohio
  • Lehigh Valley Hospital and Health Network — Allentown, Pennsylvania
  • Temple University Hospital — Philadelphia, Pennsylvania
  • University of Texas Southwestern Medical Center — Dallas, Texas
  • Virginia Commonwealth University Medical Center — Richmond, Virginia
  • UW Health University Hospital — Madison, Wisconsin
  • Bembde Hospital — Aurangabad, Maharashtra
  • National Burns Centre — Mumbai, Maharashtra

💰 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.

Explore by condition: All Burns clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗