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

NCT04090424 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP-003
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 26

Brief 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).

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NovoSorb BTM

EXPERIMENTAL

Application of NovoSorb BTM to study lesions

Device: NovoSorb BTM

Standard of Care

ACTIVE COMPARATOR

Application of the institution's standard of care to study lesions.

Procedure: Standard of Care

Interventions

NovoSorb BTM DEVICE

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.

NovoSorb BTM

Standard of Care PROCEDURE

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

Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• PolyNovo Biomaterials Pty Ltd.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (26)

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Southern California Regional Burn Center at LAC+USC

Los Angeles, California, 90033, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Loyola University of Chicago

Maywood, Illinois, 60153, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University Medical Center, New Orleans

New Orleans, Louisiana, 70112, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02446, United States

Location

New York Presbyterian Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 24157, United States

Location

Akron Children's Hospital, Burn Center

Akron, Ohio, 44308, United States

Location

The Ohio State University/ Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Lehigh Valley Hospital and Health Network

Allentown, Pennsylvania, 18103, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

Location

UW Health University Hospital

Madison, Wisconsin, 53792, United States

Location

Bembde Hospital

Aurangabad, Maharashtra, India

Location

National Burns Centre

Mumbai, Maharashtra, India

Location

Ganga Medical Centre and Hospitals PVT Ltd

Coimbatore, Tamil Nadu, India

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Burns

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marcus Wagstaff, MBBS, PhD

  Royal Adelaide Hospital, Adelaide SA 5000. Australia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 21, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3); US (23)