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Prospective Randomized International Study on the Reactivation of Burn Injuries

NCT04951934 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-07-07

No results posted yet for this study

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

Interventions

DEVICE

EmoLED

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.

PROCEDURE

Standard treatment

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.

Sponsors & Collaborators

  • Emoled

    lead INDUSTRY

Principal Investigators

  • Stefano Gasperini, MD · Medical Advisor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-01-31
Completion
2024-07-31

Countries

  • Austria
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951934 on ClinicalTrials.gov