Active — Not RecruitingNot Applicable

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

United States150 participantsStarted 2021-09-21

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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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).
✓. 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

What they're measuring

Proportion of study lesions in both groups with complete wound closure after skin grafting

Timeframe: 4 weeks after skin grafting

Trial details

NCT IDNCT04090424

SponsorPolyNovo Biomaterials Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Burns trials