Completed

NCT Number: NCT03660150

Health-related Quality of Life After Massive Burn Injury

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.

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Key information

Conditions

Patients With Massive Burn Injury

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon, Croix-Rousse Hospital

Lyon, 69004, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Evaluation of health-related quality of life

Other

Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Speciﬁc Health Scale (BSHS-B) are used for the present evaluation.

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HR - QOL MR

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Sep 6, 2018
Registry last updated: Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.