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临床试验/NCT03660150
NCT03660150已完成不适用

Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Short Form-36 Medical Outcomes Survey (SF-36) sub domain score

研究概览

简要总结

Massive burns are serious life-threatening conditions. Recent advances in their management now allow the survival of a growing number of patients. The burn care paradigm is transformed: the evaluation of survival at the end of acute care is no longer sufficient for a good evaluation of practices; the attention now focuses on long-term health-related quality of life (HR-QOL).The recently validated French translation of the burn specific health scale brief version makes this evaluation now feasible in French burn centers. The objectives of this study are to evaluate the HR-QOL of massive burn survivors, to compare it to another chronic condition (necrotizing fasciitis) and to determine the main predictive factor of health-related quality of life. This study is retrospectively conducted in 18 patients who survived a massive burn injury involving more than 80% of the total body surface area, or more than 70% of the total body surface area if the injury occured during childhood and who were treated between 1997 and 2017 in our Lyon burn center. Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Specific Health Scale (BSHS-B) are used for the present evaluation.

详细描述

The hypotheses are as follows:

  • the HR-QOL of massive burns shows a significative alteration compared to general population
  • this alteration is comparable with another chronic disease
  • the main predictors of impaired quality of life related to physical health status are hand injury, age at time of burn and time since burn
  • the main predictive factors of change in quality of life related to mental health status are age of onset and facial involvement.

研究设计

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

入排标准

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

入选标准

  • Patients over 14 years of age
  • Patients with a childhood burn reaching more than 70% of the total body surface OR Adult patients with burns of more than 80% of total body surface area
  • Patients who were treated at the burn center between January 1997 and January 2017
  • Patients who survived after initial hospitalization for burn management

排除标准

  • Patients with superficial burning, without sequelae or with extensive sequelae at less than 70% of total body surface area in children and less than 80% of total body surface area in adults
  • Patients who expressed opposition to their participation in the study

结局指标

主要结局

Short Form-36 Medical Outcomes Survey (SF-36) sub domain score

时间窗: Data concerning HR-QOL was retrospectively collected in July 2018 for all patients with a massive burn injury occuring during 1997 and 2017

The impact of massive burn injury is measured for each SF 36 sub domain and compared to general population score.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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