Health-related Quality of Life After Massive Burn Injury (HR - QOL MR)

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

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.

Study Overview

• Status: Completed
• Conditions: Patients With Massive Burn Injury
• Intervention / Treatment: Other: Evaluation of health-related quality of life

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hospices Civils de Lyon, Croix-Rousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 Medical Outcomes Survey (SF-36) sub domain score	The impact of massive burn injury is measured for each SF 36 sub domain and compared to general population score.	Data concerning HR-QOL was retrospectively collected in July 2018 for all patients with a massive burn injury occuring during 1997 and 2017

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Fabienne Braye, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: CRC_GHN_2018_003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No