Prospective Randomized International Study on the Reactivation of Burn Injuries (NCT04951934) | Clinical Trial Compass
WithdrawnNot Applicable
Prospective Randomized International Study on the Reactivation of Burn Injuries
Stopped: There has been no unanimous approval by the investigators regarding the approval of the study protocol. Therefore, by mutual agreement, sponsor and investigators have taken the decision to withdraw the clinical study.
Austria, Italy0Started 2023-01
Plain-language summary
This clinical trial will be a multi-centric prospective, randomized controlled study with the commercial objective of evaluating the clinical efficacy of a battery-powered portable device that uses blue LEDs. The clinical study aims to compare the existing standard treatment for burned areas in which the autologous skin graft was not successful, with a protocol that includes the administration of the treatment with EmoLED for 5 consecutive weeks in addition to conventional therapy.
The enrolled patients will have to be examined after 5 weeks of treatment, until complete healing and subsequently their scarring will have to be evaluated at 3 and 6 months after healing.
Who can participate
Age range
18 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:
* Subjects suffering from deep burns who have been surgically treated with autologous skin graft, whose failure has been total or partial;
* The surface of the non-taken skin graft must be between 0.5% and 5.0% of the body surface;
* Men and women aged ≥ 18 years;
* The patient must be able to understand the purpose of the Clinical Study and provide their Informed Consent in writing.
Exclusion Criteria:
* Patients who are participating in other clinical trials with drug or medical device;
* Patients who are unable to understand the aims and the objectives of the study;
* Patients with burns with TBSA greater than 50%;
* Patients with a history of self-harm who can voluntarily alter the course of healing;
* Patients with psychiatric disorders;
* Women who are pregnant or breastfeeding (the state of pregnancy or breastfeeding will be certified on the basis of the patient's declaration);
* Patients with cancer;
* Patients with pathologies that induce photosensitization of the skin;
* Patients with limited life expectancy.
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.