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

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).

Inclusion criteria

• 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.

Exclusion criteria

• 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