Clinical trial NCT03660150: Health-related Quality of Life After Massive Burn Injury
Official title: Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Massive Burn Injury
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 18
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of a massive burn injury involving more than 80% 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 a Lyon burn center

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients over 14 years of age
2. 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
3. Patients who were treated at the burn center between January 1997 and January 2017
4. Patients who survived after initial hospitalization for burn management

Exclusion Criteria:

1. 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
2. Patients who expressed opposition to their participation in the study

Primary outcomes:
measure: Short Form-36 Medical Outcomes Survey (SF-36) sub domain score
timeFrame: Data concerning HR-QOL was retrospectively collected in July 2018 for all patients with a massive burn injury occuring during 1997 and 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Croix-Rousse Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Fabienne Braye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: