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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Burns
• Intervention / Treatment: Device: NovoSorb BTM; Procedure: Standard of Care

Detailed Description

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). A comparison will be made between burn wounds treated with BTM and the institution's standard of care (SOC).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Aurangabad, Maharashtra, India
      • Bembde Hospital
    • Mumbai, Maharashtra, India
      • National Burns Centre
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India
      • Ganga Medical Centre and Hospitals PVT Ltd
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • ValleyWise Health
  • California
    • Los Angeles, California, United States, 90033
      • Southern California Regional Burn Center at LAC+USC
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Bridgeport Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University at Grady Memorial Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University of Chicago
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center, New Orleans
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02446
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian Weill Cornell Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Winston-Salem, North Carolina, United States, 24157
      • Wake Forest Baptist Health
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital, Burn Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University/ Wexner Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital And Health Network
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Health University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
2. Willing to comply with all study procedures and expects to be available for the duration of the study
3. Male and females ≥ 18 years of age and ≤ 75 years of age

4. 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
5. 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.
6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
7. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.

Exclusion Criteria:

1. Has a known hypersensitivity to polyurethane
2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
5. 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
6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation
7. Has exposure to any other investigational agent within the last 6 months
8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
9. Anticipated inability to perform wound care and follow-up procedures
10. Anticipates of a level of non-compliance
11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
12. 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
13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NovoSorb BTM; Application of NovoSorb BTM to study lesions	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.
Active Comparator: Standard of Care; Application of the institution's standard of care to study lesions.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of study lesions in both groups with complete wound closure after skin grafting	Assessment of clinical outcome by wound closure	4 weeks after skin grafting

Collaborators and Investigators

• Sponsor: PolyNovo Biomaterials Pty Ltd.
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Marcus Wagstaff, MBBS, PhD, Royal Adelaide Hospital, Adelaide SA 5000. Australia

Publications and helpful links

Helpful Links

• Sponsor website

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: CP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No