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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04090424
Other study ID # CP-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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