BurnsNCT03914560
Nutritional Intakes in Burn Patients Treated as Outpatients
An observational study of Burns and Nutritional Deficiency, run by University of Liege at 1 site in Belgium.
Trial summary
Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Burns, Nutritional Deficiency
- What is being tested?
- Burn injury
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2018to 5 Apr 2019
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All burn patients admitted in the outpatient clinic of the investigator's burn center for minor burns
Who may be able to join
- Burn treated exclusively in an outpatient clinic
Who cannot join
- Not french speaking
- Psychiatric disorders
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Macronutrients and Micronutrients Intakes in Burn Patients Treated as Outpatients
Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation.
Studies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium.
The present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.
- Conditions
- Burns, Nutritional Deficiency
- Being tested
- Burn injury
- Medical subject headings
- Burns, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burn injuryOther
minor burn injury
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional intakes
Using a standardized food questionnaire, mean daily nutritional intakes were calculated for each patient (macronutrients and micronutrients). Food questionnaire is a questionnaire created by our dietetics unit, aiming to quantify the amount of food eaten at each meal. Quantities of macronutrients and micronutrients at each meal were then calculated using tables of food content (Nubel for all nutrients, excepting vitamin E calculated according Ciqual table).
Measured: During the first week following injury
Secondary outcomes (2)
Body composition
Body composition measured using bio impedance
Measured: During the first week following injury
Handgrip strength
Strength measured an handheld dynamometer
Measured: During the first week following injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jun 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rousseau, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914560
- Sponsor's protocol ID
- ABA
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 16 Apr 2019
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Macronutrients and Micronutrients Intakes in Burn Patients Treated as Outpatients
- ClinicalTrials.gov ID
- NCT03914560
- Acronym / sponsor ID
- ABA
- Conditions
- Burns, Nutritional Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 16 Apr 2019 (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.
Nutrition is a key component of burn care. The primary goal of nutrition is to provide adequate supply in macro and micronutrients that are necessary to maintain organ function but also to wound healing, infection control and muscle preservation.
Studies about nutrition and burn care are mainly focused on severe burn patients. There is a few or no data regarding nutrition in minor burns. Those patients rarely receive a multidisciplinary approach, at least in Belgium.
The present study aimed to describe the nutritional condition of less severe burn patients treated as outpatients in a Belgian burn center. The ultimate goal was to determine whether this population needs specific dietetics follow-up or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All burn patients admitted in the outpatient clinic of the investigator's burn center for minor burns
Key inclusion criteria (1 listed)
- Burn treated exclusively in an outpatient clinic
Key exclusion criteria (3 listed)
- Not french speaking
- Psychiatric disorders
- Patient refusal
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 |
|---|---|---|
| Burn injuryminor burn injury | Other | – |
Primary outcome
nutritional intakes
Time frame: During the first week following injury
Using a standardized food questionnaire, mean daily nutritional intakes were calculated for each patient (macronutrients and micronutrients). Food questionnaire is a questionnaire created by our dietetics unit, aiming to quantify the amount of food eaten at each meal. Quantities of macronutrients and micronutrients at each meal were then calculated using tables of food content (Nubel for all nutrients, excepting vitamin E calculated according Ciqual table).
2 secondary outcomes
Body composition
Time frame: During the first week following injury
Handgrip strength
Time frame: During the first week following injury
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 16 Apr 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Burns and Nutritional Deficiency, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 3 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 16 Apr 2019. 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 Belgium. 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?
nutritional intakes (time frame: During the first week following injury). 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 16 Apr 2019.