AzTrials
AzTrials

BurnsNCT03867565

The Role of Nutrition After Minor Burns

A study testing Nutritional intervention in people with Burns and Nutritional Deficiency, run by Uppsala University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Nutrition therapy has an important role in burn care to optimize wound healing, prevent muscle wasting, improve immune function and decrease risk of infection and sepsis. The body of literature concerning major burns´nutritional requirements has increased over the last decades, however the role of nutrition after… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burns, Nutritional Deficiency
What is being tested?
Nutritional intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
No sites listed yet
Study dates
25 Mar 2019to 25 Mar 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Minor burn, TBSA < 20 %
  • Age ≥ 18 years old
  • Understands Swedish or English verbally and in writing
  • Mentally adequate
  • Oral and written informed consent.

Who cannot join

  • Patients deemed not to be able to complete study protocol.
  • TBSA < 2 %.

Trial locations and contacts

No sites are listed yet.

Josefin Dimander, PhD-student contact

+46-(0)721419359

josefin.dimander@akademiska.se

Fredrik RM Huss, Ass Prof contact

+46707941574

fredrik.huss@surgsci.uu.se

About this study

Nutrition therapy has an important role in burn care to optimize wound healing, prevent muscle wasting, improve immune function and decrease risk of infection and sepsis. The body of literature concerning major burns´nutritional requirements has increased over the last decades, however the role of nutrition after minor burns (TBSA < 20 %) is virtually unexplored and in need of further investigation. Hence, this study explores if adequate nutritional status after minor burn results in better outcome.

Read the detailed description

Phase 1 Aim To study energy- and protein requirements after minor burns in adults (TBSA < 20 %).

Research questions Do energy- and protein requirements increase after minor burns? Do energy- and protein requirements proportionally increase with the severity of injury; depth and extent after minor burns? Study design/methods Sample size: 84 patients and 84 healthy control subjects (matched by age, gender and BMI).

Method: All consecutive burns, admitted for treatment at Uppsala Burn Center, fulfilling inclusion and exclusion criteria are asked to take part in this phase. Oral and written informed consent is collected. Patients background data (severity of burn injury, including depth and extent, and the treatment thereof, concomitant diseases and medications, age, weight, height, gender, socioeconomic status, alcohol- and tobacco use, physical activity level using activity meters, as well as data from questionnaire obtained from routine standard of care at Burn Center about sleep, quality of life, pain and depression) will be collected. Measure (indirect calorimetry) and calculate energy requirement (Mifflin St Jeor equation x Injury Factor x physical activity level) within 2 weeks after injury and 1, 3, 6, and 12 months after injury. Measure nitrogen balance (nitrogen balance = nitrogen intake - nitrogen loss). Collecting data from blood sample to measure inflammatory response (albumin, transferrin, CRP), if the body can use more protein (urea) and measurement of normal kidney function (cystatin-C).Collecting data from 24-h-urine collection, urea for calculation of nitrogen balance to distinguish between protein intake compared and muscle breakdown. Data for calculation of protein intake from nutritional assessment and 4-day food record. Results are compared with 84 healthy control subjects measured with indirect calorimetry, blood sample, urine collection, and intake measurement.

Phase 2 Aim To describe nutritional status in adult patients after minor burns. Nutritional status is defined as to what degree physiological nutrient needs are met (energy- and protein intake compared to measurements and calculations, carbohydrate-, fat-, vitamin-, and mineral intake compared to estimated average requirements. Weight and muscle mass compared to normal body composition and its development over time).

Research questions Do minor burns affect nutritional status? Does nutritional status differ related to injury severity? Sample size: 84 patients included in Phase 1 are asked to take part in this study.

Method: All consecutive burns, admitted for treatment at the Uppsala Burn Center, fulfilling inclusion and exclusion criteria are asked to take part in this phase. Oral and written informed consent is collected. Patients background data from phase 1 will be collected.

Screening for nutritional risk, identifying mild, moderate and severe impaired nutritional status (undernourishment): screening tool, NRS 2002 (19), within 2 weeks from injury, and follow-up 1, 3, 6, and 12 months after injury. Screening is performed by a dietitian.

Nutritional assessment: data from phase 1 will be collected about intake, energy- and protein needs, weight and muscle mass. Dietary history interview, to collect data about patients' intake the year before injury.

Nutritional diagnosis of malnutrition (16) were nutritional risk screening and nutritional assessment will provide the basis for diagnosis.

Phase 3 Aim To identify types of nutritional diagnoses, and nutritional interventions, and the effects on signs and symptoms for respective nutritional diagnosis, in adults after minor burns.

To create a nutrition algorithm for nutritional interventions after minor burns.

Research questions Frequency of different types of aetiologies to identify nutritional diagnoses? Frequency of different types of nutritional diagnoses? Frequency and types of nutritional interventions? Is the nutrition diagnosis treated by the nutrition intervention (fully, partly, not)? Results of nutritional interventions (variable depends on signs and symptoms relevant for respective nutritional diagnosis e.g. energy- and protein intake)? Study design/methods Sample size: Patients identified as in need of nutritional intervention in phase 2 are asked to take part in this study.

Method: Oral and written informed consent is collected. Patients background data from phase 1 will be collected.

Nutritional intervention: Nutritional intervention is initiated with follow-up at dietitian's discretion. Nutrition Care Process is used:

  1. Assessing patient data (material from phases 1-2 and additional assessment at dietitian's discretion)
  2. Diagnosing nutritional problems (for example inadequate protein- energy intake, inadequate protein intake, food- and nutrition- knowledge deficit, unintended weight loss, malnutrition) and determining the problems´ aetiologies
  3. Implementing one or more interventions (for example recommendations on meal frequency, foodstuff, use of nutritional support, education on basics)
  4. Monitoring and evaluating patient progress (compliance to nutritional interventions, and sign and symptoms relevant for respective nutritional diagnosis, e.g. weight change, energy- and protein intake) Compliance to nutritional interventions: evaluated by assessing patient data at follow-up (asking patients about compliance to treatment during nutritional assessment).

Weight development: Weekly the patients' weight will be measured as long as patients have a nutritional treatment. Thereafter at follow-up 1, 3, 6, and 12 months after injury. During the patients´ stay/visits at the burn center this is done at the hospital. Thereafter to no more need of dressing changes via health care facility patients will measure weight at home/external health facility and report the number to the clinic.

Phase 4 Aim To study the role, in adults, of nutrition after minor burns (TBSA < 20 %) on outcome (wound healing and infections and body weight).

Research questions Do nutritional status and food/supplement intake affect time to heal wounds, frequency of infections, and weight changes, after minor burns? Study design/methods Sample size: 84 patients included in phase 1 are asked to take part in this phase.

Method:

All consecutive burns, admitted for treatment at the Uppsala Burn Center, fulfilling inclusion and exclusion criteria are asked to take part in the study. Oral and written informed consent is collected. Patients background data from phase 1 will be collected.

Wound healing: As surrogate parameter for number of days to wound healing the number of days from burn to no more need of dressing changes via health care facility will be measured. During routine clinical visits to the burn center, photography of wounds will be taken. Three blinded plastic surgeons with burn care experience will assess the photos for % of initial wound healed correlated to days from burn.

Frequency of infections: As surrogate parameter for frequency of infections the number, sort, dose, and length of antibiotic treatment(s) during the period from burn to no more need of dressing changes via health care facility will be measured.

Weight development: Weekly the patients´ weight will be measured. During the patients´ stay/visits at the burn center this is done at the hospital. Thereafter to no more need of dressing changes via health care facility patients will measure weight at home/external health facility and report the number to the clinic.

Nutritional assessment: Data from phases 1, 2 and 3, energy- and protein requirements, nutritional intake, muscle mass and nutritional diagnoses and the treatment thereof.

Being tested
Nutritional intervention
Keywords
Minor burns, Nutrition
Medical subject headings
Burns, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional interventionOther

    Indirect calorimetry Weight development Nitrogen balance Food records Physical activity Nutritional risk screening and assessment Inflammatory response Wound healing as number of days from burn to no more need of dressing changes via health care facility Frequency of infections as the number, sort, dose, and length of antibiotic treatment(s) from burn to no more need of dressing changes via health care facility

Study groups in NCT03867565
Study groupRoleWhat they receive
No nutritional diagnosisNo interventionPatients without nutritional diagnosis get SOC
Nutritional diagnosisExperimentalPatients with nutritional diagnosis get nutritional intervention by dietitian.
Receives: Other: Nutritional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in energy balance from trauma to 12 months after minor burns

    Resting energy expenditure (REE) measured by indirect calorimetry to study energy requirements. REE are added with measurement of physical activity level (PAL) from 4-day activity measurement and compared to energy intake (that are collected from 4-day food record) to analyze energy balance.

    Measured: within 2 weeks after injury, 1, 3, 6, 12 month after injury

  2. Change in nitrogen intake from trauma to 12 months after minor burns

    Nitrogen intake is measured and calculated from a 4-day food record

    Measured: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury.

  3. Change in nitrogen loss from trauma to 12 months after minor burns

    Nitrogen loss is calculated from 24-h-urine collection (urea).

    Measured: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury.

  4. Weight development from trauma to 12 months after minor burns

    Weight will be measured every week after trauma until no more need for dressing changes via health care facility. For all patients´ weight will also be measured within 2 weeks after injury, 1, 3, 6, 12 months after injury. During the patients´ stay/visits at the burn center this is done at the hospital. Thereafter weight will be measured at home/external health facility.

    Measured: Every week after trauma until no more need for dressing changes via health care facility and also within 2 weeks after injury, 1, 3, 6, 12 months after injury.

  5. Frequency of infection from trauma to 12 months after minor burns

    As surrogate parameter for frequency of infections the number, sort, dose, and length of antibiotic treatment(s) during the period

    Measured: within 2 weeks after injury, 1, 3, 6, 12 month after injury

  6. Wound healing from trauma to 12 months after minor burns

    As surrogate parameter for number of days to wound healing the number of days from burn to no more need of dressing changes via health care facility will be measured

    Measured: Every week after trauma until no more need for dressing changes via health care facility and also within 2 weeks after injury, 1, 3, 6, 12 months after injury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2019
  2. Study start25 Mar 2019 (estimated)
  3. Primary completion25 Mar 2023 (estimated)
  4. Study completion25 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Intervention model
Parallel groups
Model description
Patients found to have nutritional diagnosis will be given tailorized nutritional intervention.
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03867565
Sponsor's protocol ID
FOU2018-0249
Status last verified
Mar 2019
First submitted
17 Jan 2019
Last updated
8 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional intervention in people with Burns and Nutritional Deficiency, run by Uppsala University.

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 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Josefin Dimander, PhD-student (+46-(0)721419359, josefin.dimander@akademiska.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in energy balance from trauma to 12 months after minor burns (time frame: within 2 weeks after injury, 1, 3, 6, 12 month after injury). The study lists 6 primary outcomes in all. 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 8 Mar 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in