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

Not Applicable

Active, not recruiting

• Conditions: Burns
• Interventions: Procedure: Standard of Care; Device: NovoSorb BTM

• Registration Number: NCT04090424
• Lead Sponsor: PolyNovo Biomaterials Pty Ltd.

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).

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Study Start: 2021-09-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Application of the institution's standard of care to study lesions.
NovoSorb BTM	NovoSorb BTM	Application of NovoSorb BTM to study lesions

Primary Outcome Measures

Name	Time	Method
Proportion of study lesions in both groups with complete wound closure after skin grafting	4 weeks after skin grafting	Assessment of clinical outcome by wound closure

Trial Locations

Locations (26)

Valleywise Health; 🇺🇸 Phoenix, Arizona, United States

Southern California Regional Burn Center at LAC+USC; 🇺🇸 Los Angeles, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Emory University at Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Loyola University of Chicago; 🇺🇸 Maywood, Illinois, United States

University of Iowa Hospital and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

University Medical Center, New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

New York Presbyterian Weill Cornell Medicine; 🇺🇸 New York, New York, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

Akron Children's Hospital, Burn Center; 🇺🇸 Akron, Ohio, United States

The Ohio State University/ Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Lehigh Valley Hospital and Health Network; 🇺🇸 Allentown, Pennsylvania, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Virginia Commonwealth University Medical Center; 🇺🇸 Richmond, Virginia, United States

UW Health University Hospital; 🇺🇸 Madison, Wisconsin, United States

Bembde Hospital; 🇮🇳 Aurangabad, Maharashtra, India

National Burns Centre; 🇮🇳 Mumbai, Maharashtra, India

Ganga Medical Centre and Hospitals PVT Ltd; 🇮🇳 Coimbatore, Tamil Nadu, India