Prospective Randomized International Study on the Reactivation of Burn Injuries

NCT04951934 | Withdrawn

• 1 other identifier: EmoLED_Burn_001
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Burns; Skin Graft (Allograft)(Autograft) Failure

Keywords

Burns; Graft; Autograft; EmoLED; blue light; LED; blue LED; wound healing

Outcome Measures

Primary Outcomes (1)

• Patient with an at least 30% area reduction

  Percentage of patients in the two groups who, after 5 weeks of treatment, achieve a percentage reduction in the wound area of at least 30%.

  5 weeks

Secondary Outcomes (4)

• Percentage surface change

  5 weeks

• Healing time

  6 months

• Scarring

  6 months

• Adverse events

  6 months

Study Arms (2)

EmoLED Group

EXPERIMENTAL

The EmoLED Group will undergo treatment with EmoLED twice a week for 5 consecutive weeks. The therapy, in this case, in addition to the standard treatment, will also include a treatment with the EmoLED device.

Device: EmoLED; Procedure: Standard treatment

Control Group

ACTIVE COMPARATOR

The Control Group will follow the standard treatment indicated.

Procedure: Standard treatment

Interventions

EmoLED DEVICE

This treatment consists of irradiation with the blue light emitted by the device for one minute on the injured area. If the wound has a greater extension than the irradiated area, multiple repeated applications will be performed on adjacent areas, until the entire wound is covered.

EmoLED Group

Standard treatment PROCEDURE

The standard treatment consists of: cleansing and possible debridement of the wound, application of the topical treatment indicated for that phase of the wound, intended as the "standard of care" of the structure, and subsequent bandaging.

Also known as: SOC

Control Group; EmoLED Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emoled: lead

Study Sites (6)

Medical University of Graz - Department of Surgery - Division of Plastic, Reconstructive and Aesthetic Surgery

Graz, 8036, Austria

Location

AO for emergency "Cannizzaro" - Big Burns Center

Catania, 95126, Italy

Location

Plastic Surgery - Centro Ustioni ASL3 Liguria - Hospital Villa Scassi

Genova, 16149, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

Location

AO Cardarelli - UOC Big Burns Center - Reconstructive Plastic Surgery

Napoli, 80131, Italy

Location

AOU Pisana - Sede di Cisanello - UO Burns Center

Pisa, 56124, Italy

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Stefano Gasperini, MD

  Medical Advisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since this is an experiment with a medical device that emits blue light, in this case the masking of the assignment to one of the two groups cannot be carried out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centric prospective, randomized controlled study

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 7, 2021
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

IT (5); AU (1)