The trial is taking place at:

Baton Rouge General Medical Center | Clinical Trials Office

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


PolyNovo North America






Procedure: Standard of Care
Device: NovoSorb BTM

Study type


Funder types

Other U.S. Federal agency



Details and patient eligibility


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).

Full 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).


150 estimated patients




18 to 75 years old


No Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Parallel Assignment


None (Open label)

150 participants in 2 patient groups

NovoSorb BTM
Experimental group
Application of NovoSorb BTM to study lesions
Device: NovoSorb BTM
Standard of Care
Active Comparator group
Application of the institution's standard of care to study lesions.
Procedure: Standard of Care

Trial contacts and locations



Central trial contact

Kim Bradbury

Data sourced from

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