Health-related Quality of Life After Massive Burn Injury

Completed

• Conditions: Patients With Massive Burn Injury

• Registration Number: NCT03660150
• Lead Sponsor: Hospices Civils de Lyon

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-07-31
• Status Verified: 2018-08
• Study Completion: 2018-08-31
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form-36 Medical Outcomes Survey (SF-36) sub domain score	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon, Croix-Rousse Hospital; 🇫🇷 Lyon, France