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 range18 Years

SexALL

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.

What they're measuring

Patient with an at least 30% area reduction

Timeframe: 5 weeks

Trial details

NCT IDNCT04951934

SponsorEmoled

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01