The Role of Nutrition After Minor Burns

• ClinicalTrials.gov Identifier: NCT03867565
• Recruitment Status: Not yet recruiting
• First Posted: March 8, 2019
• Last Update Posted: March 8, 2019
• Sponsor: Uppsala University
• Information provided by (Responsible Party): Uppsala University

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Burns; Nutritional Deficiency	Other: Nutritional intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients found to have nutritional diagnosis will be given tailorized nutritional intervention.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Role of Nutrition After Minor Burns
• Estimated Study Start Date: March 25, 2019
• Estimated Primary Completion Date: March 25, 2023
• Estimated Study Completion Date: March 25, 2025

Arms and Interventions

Arm	Intervention/treatment
No Intervention: No nutritional diagnosis; Patients without nutritional diagnosis get SOC
Experimental: Nutritional diagnosis; Patients with nutritional diagnosis get nutritional intervention by dietitian.	Other: Nutritional intervention; 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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.
2. Change in nitrogen intake from trauma to 12 months after minor burns [ Time Frame: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury. ]
   Nitrogen intake is measured and calculated from a 4-day food record
3. Change in nitrogen loss from trauma to 12 months after minor burns [ Time Frame: Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury. ]
   Nitrogen loss is calculated from 24-h-urine collection (urea).
4. Weight development from trauma to 12 months after minor burns [ Time Frame: 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. ]
   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.
5. Frequency of infection from trauma to 12 months after minor burns [ Time Frame: within 2 weeks after injury, 1, 3, 6, 12 month after injury ]
   As surrogate parameter for frequency of infections the number, sort, dose, and length of antibiotic treatment(s) during the period
6. Wound healing from trauma to 12 months after minor burns [ Time Frame: 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 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Josefin Dimander, PhD-student; +46-(0)721419359; josefin.dimander@akademiska.se

Contact: Fredrik RM Huss, Ass Prof; +46707941574; fredrik.huss@surgsci.uu.se

Sponsors and Collaborators

Uppsala University

Investigators

• Principal Investigator: Fredrik RM Huss, Ass Prof; Burn Center, Dept. of Plastic and Maxillofacial Surgery

More Information

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT03867565
• Other Study ID Numbers: FOU2018-0249
• First Posted: March 8, 2019
• Last Update Posted: March 8, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:

Minor burns; Nutrition

Additional relevant MeSH terms:

Malnutrition; Burns; Wounds and Injuries; Nutrition Disorders