Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of… (NCT05462860) | Clinical Trial Compass
RecruitingNot Applicable
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
United States21 participantsStarted 2024-09-18
Plain-language summary
The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.
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:
* Male or Female ≥18 years and ≤75 years
* Acute partial thickness burns by friction, contact, scalding from hot liquids and flame
* TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet
* TBSA 3rd ≤5 % (not to be included as burn treatment region of interest)
* Subject is able and willing to sign Informed Consent or via legally authorized representative
Exclusion Criteria:
* Study Wound due to electrical, radioactive, or frostbite-related injury
* Infection of wounds in the study area at admission per Investigator or treating physician discretion
* Pregnancy/lactation
* Subjects who are unable to follow the protocol or who are likely to be non-compliant
* Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
* Prisoners
* Life expectancy less than 6 months
* Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment
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.