Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-27 @ 4:46 PM
Study NCT ID:
NCT03660150
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2018-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health-related Quality of Life After Massive Burn Injury
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HR - QOL MR
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 Speciļ¬c 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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: