Thermal injuries to the skin with a body surface area (BSA) of 1–20%
Conditions
Interventions
Group 1: The metabolism, or resting energy expenditure, of patients with minor and moderate burns covering 1–20% of the body surface area (VKOF) will be assessed at four time points (within 48 hours a
Sponsors
BG Universitätsklinikum Bergmannsheil Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Acute thermal injury to the skin due to a burn or scald, with a burned body surface area of =1% and <20% of total body surface area (TBSA), based on second-degree or deeper burn areas. Presentation or treatment at the study center within 48 hours of the injury Ability to perform the first indirect calorimetry test within 48 hours of the injury. Spontaneous breathing and clinical ability to undergo indirect calorimetry in the specified measurement mode. Clinical feasibility of a standardized ultrasound examination of both thighs to determine QMLT and RF-CSA. Capacity to give informed consent, as well as written consent to participate in the study following full explanation. Willingness and anticipated ability to participate in the scheduled follow-up measurements through and including Month 3.
Exclusion criteria
Exclusion criteria: Age 20% of the body surface area (VKOF) Presentation at the study center >48 hours after trauma Thermal injuries to the face
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are resting energy expenditure (REE) in kcal/24 h, as determined by indirect calorimetry, and the presence of hypermetabolism at the measurement time points upon study enrollment, on Day 7, on Day 28, and after three months. Hypermetabolism is defined as oxygen consumption (VO2) measured at rest of = 3.5 ml/kg/min. Another primary endpoint is the difference between the REE measured by indirect calorimetry and the resting energy expenditure calculated using predictive equations, expressed as an absolute difference in kcal/24 h and as a relative difference as a percentage of the measured REE. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints of the study are the parameters of regional muscle size measured using standardized quadriceps ultrasound, in particular the quadriceps muscle layer thickness (QMLT) and the rectus femoris cross-sectional area (RF-CSA), each reported as absolute values and as changes from baseline over the course of the study. Additional secondary endpoints include clinical factors influencing metabolic outcomes, specifically body surface area burned, burn depth, location of the thermal injury, need for surgical treatment, timing and type of wound coverage, as well as wound healing progress or the presence of open wound surfaces at the respective measurement time points. In addition, exploratory analyses will examine correlations between measured resting energy expenditure, the presence of hypermetabolism, and ultrasound-based muscle parameters. Furthermore, standardized data on dietary intake and activity levels will be collected as secondary and exploratory endpoints, respectively, and evaluated in relation to metabolic and muscular progression. | — |
Countries
Germany
Contacts
Public ContactJannik Hinzmann
Klinik für Plastische Chirurgie des BG Universitätsklinikums Bergmannsheil Bochum
Outcome results
None listed