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

Study Overview
=================
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).

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

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Device: NovoSorb BTM
* Procedure: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NovoSorb BTM<br>Application of NovoSorb BTM to study lesions | Device: NovoSorb BTM<br>* 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.<br>|
| Active Comparator: Standard of Care<br>Application of the institution's standard of care to study lesions. | Procedure: Standard of Care<br>* Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |