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

Running, not enrolling · Not applicable

Conditions studied: Burns

In brief

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).

Key facts

Study ID

NCT04090424

Run by

PolyNovo Biomaterials Pty Ltd.

People needed

150

Starts

2021-09-21

Expected to finish

2026-12-01

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
• Willing to comply with all study procedures and expects to be available for the duration of the study
• Male and females ≥ 18 years of age and ≤ 75 years of age
• Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).
• Types of burns include the following:
• Scalding including from hot water, cooking oil, grease
• Flame
• Flash
• Contact
• Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft.
• The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
• Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.

You may not qualify if…

• Has a known hypersensitivity to polyurethane
• Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
• Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
• Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
• Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound
• For females - has known or suspected pregnancy, planned pregnancy, or during lactation
• Has exposure to any other investigational agent within the last 6 months
• Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
• Anticipated inability to perform wound care and follow-up procedures
• Anticipates of a level of non-compliance
• The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
• Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
• The use of NovoSorb® BTM on the face and in the perineum area is not permitted

Where it is running

• 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

Full record on ClinicalTrials.gov

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