跳至主要内容
临床试验/NCT03702972
NCT03702972撤回不适用

Contribution of Thermal Imaging in Determining the Depth of Pediatric Acute Burns: a Prospective Observational Study

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 40 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
40
主要终点
Temperature difference between burned zone and adjacent or contralateral healthy zone at time T3

研究概览

简要总结

The need to cover a burn with a skin graft is determined primarily by its depth. In fact only burns of the second deep degree or the third degree are likely to be grafted. However, if the diagnosis is obvious in the case of third degree burns, second degree burns are often "mixed" with more or less deep areas, especially in pediatrics.

Clinical experience and daily observation of the burn since its occurrence currently determine the indication for surgery. In practice, it is rare to be able to determine with certainty whether a second degree mixed burn will require a graft before the 10-12th day of evolution. There are currently devices that can help refine the diagnosis such as laser Doppler, but they are expensive devices, and not 100% reliable. The thermal camera Flir-one® attaches to a smartphone or tablet and allows thanks to a free application, to obtain a thermogram of the pointed area. This is a device used to detect insulation deficits in the building sector. Knowing that a deep burn, by devascularization, will have an external temperature lower than a superficial burn, a thermogram would thus make it possible to better identify the deep zones and the superficial zones of the burn. One study showed a good sensitivity and specificity of the device but it was a population of adult patients. This determined that a difference in skin temperature between a deep burned area and healthy skin should be at least 1.15 ° C in favor of healthy skin, to retain a burn as deep, and not to operate so-called superficial burn if this difference was below this threshold. However, further studies would be needed to demonstrate the validity of this method in clinical practice.

详细描述

All patients under 18, with acute burns (<10 days of development), surface area <10%, second degree, hospitalized from 22/01/18 in the plastic surgery department and burns Trousseau Hospital in Paris, subject to the non-opposition of parental authority. 500000 pediatric burns are counted each year in France. In 2005, they resulted in 5109 hospital stays 2. Improving the accuracy of the diagnosis before 10 days of evolution would make it possible to graft the children who needed it more quickly and thus shorten the length of hospital stay. It is therefore a public health issue, with a significant medical and economic impact.

Description of the item (s) being researched

It involves collecting, through a thermal camera, a temperature difference between a second-degree burn zone and an adjacent healthy zone, in order to prove that this difference, can make it possible to retain the burn as deep, and can therefore guide a surgical decision.

Justification of the duration of the research.

According to the same study in adults1, the number of patients to be included was 41 to obtain sufficient power for a statistical analysis of the same data collected in this study, and according to the same methodology. A duration of 4 months seems compatible with such recruitment in the specialized center for treating pediatric burns at the Trousseau Hospital in Paris.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age <18 years,
  • Acute burns (<10 days of evolution) of the second degree
  • Body surface burned <10% of total body area
  • Hospitalized patients for a period of 4 months and 15 days in the plastic surgery and burns department at Trousseau Hospital in Paris.
  • Affiliates to the general system of social security as having the right of the holders of parental authority

排除标准

  • Burns of the first degree,
  • Third degree burns,
  • fever episode not caused by burning,
  • Surgical procedure on burn before measurement,
  • Impossibility to communicate with the holders of the parental authority or opposition formulated to the participation

结局指标

主要结局

Temperature difference between burned zone and adjacent or contralateral healthy zone at time T3

时间窗: day 7 to day 10 from the day of the burn occurrence

Δ T3 will be recorded from day 7 to day 10 once by the Flir One Thermal Imager

次要结局

  • Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T2(day 4 to day 7 from the day of the burn occurrence)
  • Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T1(day 1 to day 4 from the day of the burn occurrence)

研究者

申办方类型
Other
责任方
Sponsor

相似试验