Prospective, Randomized Controlled, Multi-center Study on the Reactivation of the Reparative Process and Scarring Outcome, in Patients Treated With the EmoLED Medical Device, With Deep Burns in Which the Autologous Skin Graft Has Failed

Brief Summary

Detailed Description

Burns are the fourth most common type of trauma in the world, after traffic accidents, falls and personal violence. Around 11 million people worldwide used medical treatment for burns in 2004. The risk of burns increases with the lowering of the socioeconomic status. Of these burn victims, about 2% need hospitalization and about 0.5% need to be hospitalized in specialized centers. In deep burns, the surgical procedure of autologous skin transplant (autograft) is almost always the preferred way to induce a re-epithelization of the injured area. The coverage of a deep burn with the graft is -depending on the case case- immediate, delayed a few days after excision or late, after a first phase of direct scarring. Numerous are the types of surgery as well as the sites of skin removal. The autologous graft, however, presents a not negligible probability of failure that leads to the total or partial detachment of the grafted skin; when this happens the healing process of the lesion (or a part of it) uncovered occurs by second intention but is not always easy to manage, as this process can be delayed or stopped by many factors. Known factors contributing to this are, for example, diabetes, infections, metabolic deficiencies and the advanced age of the subject, while others are still being studied. Therefore, proper wound management and dressing after surgery, trauma or disease is an important part of the healing process, not only to prevent the onset of infections or other complications, but also to accelerate wound healing itself with as little scarring as possible. This clinical study will be a multi-centric prospective, randomized controlled parallel group, superiority study, with the commercial objective of evaluating the clinical efficacy of a battery-powered portable device that uses blue LEDs. The Study aims, within the planned observation weeks, to clinically compare two groups of patients with deep burn injuries whose autologous skin graft has failed in part or totally. The objective is to determine any differences in outcome between the two groups considered and whether the therapy of the treatment group is a valid alternative to the current therapy in terms of reactivation and support of the reparative process, speed of healing and scarring. Group 1, the "Control" group, will follow the standard treatment provided by the hospital protocol; Group 2, the "Treated" one, will follow the standard treatment provided by the hospital protocol to which is added the treatment with the EmoLED device, scheduled between the cleansing and the dressing. The measurement of the difference in efficacy of the device between the two arms will be evaluated in terms of reactivation of the healing process, intended as the achievement of a re-epithelialization of at least 30%, speed (time) of healing and scarring (Vancouver scale). The clinical trial in question aims, therefore, to investigate whether the group of patients undergoing standard therapy with, in addition, the treatment with EmoLED reaches a higher percentage of reactivations of the healing process than the one of the control group, subjected to standard treatment. If confirmed, this result would imply significant gains in terms of speeding up hospital stay for those patients where autologous grafts have not been successful, therefore also in terms of reducing public health expenditure, not to mention that, if the improvement of scarring results were confirmed in the Treated group, it would increase the quality of life of patients with burn scars which often significantly impact on this parameter. The population subject of this trial is widely representative of the target population, as there are no particular exclusion criteria and the sites involved are structures of excellence in the treatment of burns and failed skin grafting areas.

Primary Outcomes

Secondary Outcomes

• Scarring(6 months)
• Healing time(6 months)
• Percentage surface change(5 weeks)
• Adverse events(6 months)