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

Burns Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090424
• Other study ID #: CP-003
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: PolyNovo Biomaterials Pty Ltd.
• Contact: Kim Bradbury
• Phone: +1(949) 542-0950
• Email: kim.b[@]polynovo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre	Toronto	Ontario
India	Bembde Hospital	Aurangabad	Maharashtra
India	Ganga Medical Centre and Hospitals PVT Ltd	Coimbatore	Tamil Nadu
India	National Burns Centre	Mumbai	Maharashtra
United States	Akron Children's Hospital, Burn Center	Akron	Ohio
United States	Lehigh Valley Hospital and Health Network	Allentown	Pennsylvania
United States	Emory University at Grady Memorial Hospital	Atlanta	Georgia
United States	University of Colorado Hospital, Burn Center and Frost Center	Aurora	Colorado
United States	Baton Rouge General Medical Center	Baton Rouge	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Loyola University of Chicago	Chicago	Illinois
United States	The Ohio State University/ Wexner Medical Center	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Iowa Hospital and Clinics	Iowa City	Iowa
United States	University of Kansas Hospital	Kansas City	Kansas
United States	University of Nevada, Las Vegas, School of Medicine	Las Vegas	Nevada
United States	Southern California Regional Burn Center at LAC+USC	Los Angeles	California
United States	UW Health University Hospital	Madison	Wisconsin
United States	Loyola University of Chicago	Maywood	Illinois
United States	University Medical Center, New Orleans	New Orleans	Louisiana
United States	New York Presbyterian Weill Cornell Medicine	New York	New York
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Valleywise Health	Phoenix	Arizona
United States	Legacy Emanuel Medical Center, and the Oregon Burn Center	Portland	Oregon
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia
United States	University of California Davis Medical Center	Sacramento	California
United States	Tampa General Hospital	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
PolyNovo Biomaterials Pty Ltd.	Biomedical Advanced Research and Development Authority

Countries where clinical trial is conducted

United States,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Sponsor website