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ACTIVE NOT RECRUITING
NCT04090424
NA

Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

Sponsor: PolyNovo Biomaterials Pty Ltd.

View on ClinicalTrials.gov

Summary

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-09-21

Completion Date

2026-12

Last Updated

2026-02-24

Healthy Volunteers

No

Conditions

Interventions

DEVICE

NovoSorb BTM

NovoSorb BTM comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a nonbiodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.

PROCEDURE

Standard of Care

Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.

Locations (26)

Valleywise Health

Phoenix, Arizona, United States

Southern California Regional Burn Center at LAC+USC

Los Angeles, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Tampa General Hospital

Tampa, Florida, United States

Emory University at Grady Memorial Hospital

Atlanta, Georgia, United States

Loyola University of Chicago

Maywood, Illinois, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

University of Kansas Hospital

Kansas City, Kansas, United States

University Medical Center, New Orleans

New Orleans, Louisiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

New York Presbyterian Weill Cornell Medicine

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Akron Children's Hospital, Burn Center

Akron, Ohio, United States

The Ohio State University/ Wexner Medical Center

Columbus, Ohio, United States

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

UW Health University Hospital

Madison, Wisconsin, United States

Bembde Hospital

Aurangabad, Maharashtra, India

National Burns Centre

Mumbai, Maharashtra, India

Ganga Medical Centre and Hospitals PVT Ltd

Coimbatore, Tamil Nadu, India