Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns (NCT04839523) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
United States44 participantsStarted 2021-03-10
Plain-language summary
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit.
Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.
Who can participate
Age range
4 Weeks
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
. Signed informed consent
. Burn of thermal origin
. Patients presenting with partial thickness burns covering \< 5% TBSA for study treatment
. TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
. Clean wounds with ≤10% necrotic tissue
. Patients presenting with moderate to high exuding wounds
. Serous or Serosanguinous exudate
. Patient is not contraindicated for the dressing to which he/she is assigned
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.
. Chemical Burns including acidic or basic sources
. Ionizing radiation injuries
. Dry wounds
. Neonates
. Patients with delayed presentation for burn care (\>72 hours from time of injury)
. Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
. Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment