The Role of Nutrition After Minor Burns
1 other identifier
interventional
84
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2019
CompletedFirst Posted
Study publicly available on registry
March 8, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2025
CompletedMarch 8, 2019
March 1, 2019
4 years
January 17, 2019
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
within 2 weeks after injury, 1, 3, 6, 12 month after injury
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 within 2 weeks after injury, 1, 3, 6, 12 months after injury.
Change in nitrogen loss from trauma to 12 months after minor burns
Nitrogen loss is calculated from 24-h-urine collection (urea).
Measured within 2 weeks after injury, 1, 3, 6, 12 months after injury.
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.
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.
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
within 2 weeks after injury, 1, 3, 6, 12 month after injury
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
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
Study Arms (2)
No nutritional diagnosis
NO INTERVENTIONPatients without nutritional diagnosis get SOC
Nutritional diagnosis
EXPERIMENTALPatients with nutritional diagnosis get nutritional intervention by dietitian.
Interventions
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
Eligibility Criteria
You may qualify if:
- Minor burn, TBSA \< 20 %
- Age ≥ 18 years old
- Understands Swedish or English verbally and in writing
- Mentally adequate
- Oral and written informed consent.
You may not qualify if:
- Patients deemed not to be able to complete study protocol.
- TBSA \< 2 %.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik RM Huss, Ass Prof
Burn Center, Dept. of Plastic and Maxillofacial Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2019
First Posted
March 8, 2019
Study Start
March 25, 2019
Primary Completion
March 25, 2023
Study Completion
March 25, 2025
Last Updated
March 8, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share