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

PolyNovo North America

Status: Enrolling

Conditions: Burns

Treatments: Procedure: Standard of Care; Device: NovoSorb BTM

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04090424

CP-003

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

NovoSorb BTM

Experimental group

Description:

Application of NovoSorb BTM to study lesions

Treatment:

Device: NovoSorb BTM

Standard of Care

Active Comparator group

Description:

Application of the institution's standard of care to study lesions.

Treatment:

Procedure: Standard of Care