Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns (NCT04090424) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
United States, India150 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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of study lesions in both groups with complete wound closure after skin grafting
. 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