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

Purpose

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).

Condition

  • Burns

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NovoSorb BTM 		Application of NovoSorb BTM to study lesions
  • 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.
Active Comparator
Standard of Care 		Application of the institution's standard of care to study lesions.
  • 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.

More Details

Status
Active, not recruiting
Sponsor
PolyNovo Biomaterials Pty Ltd.

Study Contact

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).