Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study (NCT04202289) | Clinical Trial Compass
CompletedPhase 3
Use of Nile Tilapia Fish Skin as a Xenograft for Burn Treatment: Phase III Study
Brazil115 participantsStarted 2017-04-03
Plain-language summary
The present study is a Phase III Randomized Clinical Trial aiming to evaluate the efficacy of Nile tilapia (Oreochromis niloticus) skin as an occlusive biological dressing in the treatment of superficial partial-thickness burns in adults.
Who can participate
Age range
18 Years – 60 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:
* Age ≥ 18 and ≤60 years.
* Presence of dermatological wounds caused by superficial partial-thickness burns (SPTB) affecting up to 15% of Total Body Surface Area (TBSA).
* Patient with indication for outpatient treatment.
Exclusion Criteria:
* Previous treatment for the current burn.
* Presence of other significant diseases that could impact the volunteer's participation in the study (coronary artery disease, peripheral vascular disease, cancer, diabetes mellitus, among others).
* Hypersensitivity to materials used in the study or to related compounds.
* History of severe adverse reactions; drug addiction, including alcohol.
* Use of medications that could have an impact on wound healing (e.g., steroids).
* Pregnancy, labor or miscarriage in the 12 weeks before the scheduled start of 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.
What they're measuring
1
Number of days for complete reepithelialization of the burn wound
Timeframe: Day 11
2
Number of dressings performed
Timeframe: Day 11
3
Amount of anesthetics used throughout the treatment
Timeframe: Day 11
4
Treatment cost per patient
Timeframe: Day 11
Trial details
NCT IDNCT04202289
SponsorNucleo De Pesquisa E Desenvolvimento De Medicamentos Da Universidade Federal Do Ceara