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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Patient with an at least 30% area reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Patient with an at least 30% area reduction
时间窗: 5 weeks
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%.
次要结局
- Scarring(6 months)
- Healing time(6 months)
- Percentage surface change(5 weeks)
- Adverse events(6 months)