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

Launched by POLYNOVO BIOMATERIALS PTY LTD. · Sep 12, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to treat severe burns using a product called NovoSorb® Biodegradable Temporizing Matrix (BTM). The study aims to see how safe and effective this treatment is for patients with deep or full-thickness burns, which are burns that affect deeper layers of the skin. Participants in the study should be adults aged 18 to 75 who have burns covering between 3% and 60% of their body. Common types of burns included are those from hot water, flames, and contact with hot surfaces.

If you or a loved one are considering joining the trial, you would need to agree to follow the study procedures and provide consent. Participants would have the NovoSorb® BTM applied to their burns, and the study will monitor how well it works and its safety throughout the treatment process. It's important to note that certain individuals, such as those with specific medical conditions or infections, may not be eligible to participate. Overall, this trial could provide valuable information on a promising new treatment for people with severe burns.

Gender

ALL

Eligibility criteria

• 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