Clinical trial NCT04090424: Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: PolyNovo Biomaterials Pty Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2019-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of study lesions in both groups with complete wound closure after skin grafting
timeFrame: 4 weeks after skin grafting
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Valleywise Health
state: Arizona
city: Los Angeles
country: United States
facility: Southern California Regional Burn Center at LAC+USC
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University at Grady Memorial Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: New Orleans
country: United States
facility: University Medical Center, New Orleans
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital, Burn Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University/ Wexner Medical Center
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Hospital and Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Madison
country: United States
facility: UW Health University Hospital
state: Wisconsin
city: Aurangabad
country: India
facility: Bembde Hospital
state: Maharashtra
city: Mumbai
country: India
facility: National Burns Centre
state: Maharashtra
city: Coimbatore
country: India
facility: Ganga Medical Centre and Hospitals PVT Ltd
state: Tamil Nadu
Study officials:
affiliation: Royal Adelaide Hospital, Adelaide SA 5000. Australia
name: Marcus Wagstaff, MBBS, PhD
role: STUDY_DIRECTOR
References: