Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dre… (NCT05424354) | Clinical Trial Compass
RecruitingPhase 4
Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing
United States60 participantsStarted 2022-05-26
Plain-language summary
This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 72 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.
Who can participate
Age range
18 Years – 65 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:
* Hospitalized patients who are receiving burn care; patients may be discharged when clinically stable and continue with outpatient treatment.
* Men and women (women cannot be pregnant or breast feeding) ages 18-65 years old
* Wounds must be partial thickness, involving up to 20% of the total body surface area.
* Burn injury should be less than 72 hours old
* Willing and able to comply with protocol mandated scheduled study visits/clinical evaluations.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Known allergy to TPD or its components
* Women who are pregnant, breast feeding, or plan to get pregnant during the study period.
* Infected wounds
* Presence of any full thickness (third degree) burns
* Electrical burns
* Heavily draining burns due to underlying chronic lymphedema or other conditions
* Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
* History of poor wound healing and/or skin/immune system condition
* Deemed by clinician not to be suitable
* Unwilling or not able to provide consent or comply with protocol or required visits
* Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
* Active alcohol or substance abuse
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
Pain from the Burn Wound
Timeframe: 28 days (or sooner if the wound heals prior to 28 days)