Patients With Massive Burn InjuryHR - QOL MRNCT03660150
Health-related Quality of Life After Massive Burn Injury
An observational study of Patients With Massive Burn Injury, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Patients With Massive Burn Injury
- What is being tested?
- Evaluation of health-related quality of life
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Patients With Massive Burn Injury
- Being tested
- Evaluation of health-related quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of health-related quality of lifeOther
Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Specific Health Scale (BSHS-B) are used for the present evaluation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data concerning HR-QOL was retrospectively collected in July 2018 for all patients with a massive burn injury occuring during 1997 and 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start1 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Massive Burn InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Braye, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660150
- Sponsor's protocol ID
- CRC_GHN_2018_003
- Acronym
- HR - QOL MR
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Health-related Quality of Life After Massive Burn Injury : A Twenty Years' Experience in a Burn Center
- ClinicalTrials.gov ID
- NCT03660150
- Acronym / sponsor ID
- HR - QOL MR / CRC_GHN_2018_003
- Conditions
- Patients With Massive Burn Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of health-related quality of lifeShort Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Specific Health Scale (BSHS-B) are used for the present evaluation. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Braye, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Massive Burn Injury, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.