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Trial registered on ANZCTR


Registration number
ACTRN12620000388910
Ethics application status
Approved
Date submitted
5/03/2020
Date registered
23/03/2020
Date last updated
23/03/2020
Date data sharing statement initially provided
23/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding nutritional requirements of severe burn injury patients treated with a new skin substitute by directly measuring their individual energy expenditure.
Scientific title
Determination of nutritional requirements for severe burn injury patients requiring application of Novosorb® BTM using indirect calorimetry: a pilot study
Secondary ID [1] 300723 0
Nil Known
Universal Trial Number (UTN)
U1111-1249-2784
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Burn injury 316542 0
Condition category
Condition code
Surgery 314785 314785 0 0
Other surgery
Injuries and Accidents 314853 314853 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Energy expenditure will be measured at pre-determined times (pre and post-surgery and weekly until discharge/fully healed or 12 months whichever is sooner) using indirect calorimetry. Resting energy expenditure will be measured using the Cosmed Q-NRG™, in accordance with manufacturer recommendations. Testing will be performed in a thermo-neutral environment with participants lying supine. Patients in the intensive care unit on ventilator support will have measurements conducted via an adaptor which attaches to the ventilator. Spontaneously breathing patients will have measurements conducted using a transparent ventilated hood (canopy attachment); during the measurement period, they will be asked to remain as relaxed as possible without falling asleep and instructed not to talk or fidget. All feeding and procedures (including dressing changes) will be completed at least 1 hour prior to indirect calorimetry measurements being conducted, to minimise the effect that these may have on resting energy expenditure. Indirect calorimetry assessments will be conducted by the treating/research dietitian, trained in the use of the equipment. All measurements will be collected face-to-face, at the Royal Adelaide Hospital, Central Adelaide LHN. It is anticipated, based on manufacurer information, that on average measurements should take between 20-30 minutes.Informed consent will be obtained from all participants, and they will receive a participant information sheet with written information pertaining to the trial.
Intervention code [1] 317044 0
Other interventions
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323142 0
Resting energy expenditure (REE), measured via indirect calorimertry
Timepoint [1] 323142 0
Pre and post each surgical intervention, then weekly until discharge from hospital for the length of their inpatient stay. The number of measurements will vary per participant, depending on their length of stay which is dictated by their injury size and severity. There will be no further measurements or assessment once patients are discharged from their acute stay.
Secondary outcome [1] 380948 0
Difference between measured energy requirements from indirect calorimetry readings and standard predictor equations calculations used per current feeding protocols to determine accuracy of predictor equations.
Timepoint [1] 380948 0
Actual daily energy intake (calculated from food intake record) versus prescribed daily energy intake (as determined via indirect calorimetry), at each timepoint for measured REE (pre/post each surgical intervention (within 24 hours) and then weekly until discharge)

Eligibility
Key inclusion criteria
This study aims to recruit adult patients (18 years or greater) with equal to or greater than 20% TBSA full-thickness burns requiring BTM application as part of their surgical management, admitted over a 12 month period
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe head injury, age <18 years of age, known pre-existing inborn errors of metabolism, claustrophobia, inability to obtain informed consent (from patient or family members)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Continuous variables will be compared using Student’s t-test, Wilcoxon rank sum test, one-way analysis of variance (ANOVA) and the Kruskal–Wallis test where appropriate. Where necessary, log2 transformation of continuous data will be performed to achieve normal distribution for these analyses.
Differences between proportions derived from categorical data will be analysed using Pearson’s chi-Squared test or Fisher’s exact test where appropriate.
Descriptive presentation of data will also be employed to assist visualization where alternate statistical analyses are inappropriate. Comparisons between measured and predicted energy requirements will be made to assess for agreement between the two methodologies employed as a basis for nutritional prescriptions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16061 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29574 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 305172 0
Other Collaborative groups
Name [1] 305172 0
Allied Health research Collaborative Funding: University of South Australia, The Hospital Research Foundation & SA Health
Address [1] 305172 0
Enquiries to: Prof Susan Hillier
Division of Health Sciences I University of South Australia
P7-17 North Tce, City East
GPO Box 2471, Adelaide SA 5001
Email: susan.hillier@unisa.edu.au
Phone: +61 (0)8 8302 2544; 0419 034578
CRICOS provider no: 00121B
Country [1] 305172 0
Australia
Funding source category [2] 305174 0
Hospital
Name [2] 305174 0
Royal Adelaide Hospital
Address [2] 305174 0
1 Port Rd.
Adelaide
SA
5000
Country [2] 305174 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
1 Port Rd
Adelaide
SA
5000
Country
Australia
Secondary sponsor category [1] 305532 0
None
Name [1] 305532 0
Address [1] 305532 0
Country [1] 305532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305534 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305534 0
Royal Adelaide Hospital
Clinical Trial Centre
Level 3, Wayfinder 3D460.02
Port Road
ADELAIDE SA 5000
Ethics committee country [1] 305534 0
Australia
Date submitted for ethics approval [1] 305534 0
19/09/2019
Approval date [1] 305534 0
14/10/2019
Ethics approval number [1] 305534 0
12099

Summary
Brief summary
We propose to undertake a 12-month intervetion study to measure energy requirements of severe burn injury patients who have undergone application of Novosorb® Biodegradable Temporising Matrix (BTM) as part of their surgical management. BTM is a relatively new dermal substitute now used at the Royal Adelaide Hospital (RAH) and other burns units nationally and internationally. The nutritional requirements for ensuring optimal integration of this product prior to surgical wound closure has not been studied previously, and current nutritional prescriptions are based on predictive equations developed from historic surgical and therapy techniques.
Energy expenditure will be measured at pre-determined times (pre- and post-surgery and weekly until discharge) using indirect calorimetry, which represents the gold standard for assessment of energy expenditure. This will enable real-time adjustment of nutritional prescriptions to meet measured energy requirements determined via indirect calorimetry.
As part of this study, we will also collect actual energy and protein intake data, to determine the adequacy of the nutrition prescription delivered.
In order to ascertain how measured energy requirements compare to the conventional use of predictive equations in this population, a comparison of measured vs predicted requirements at each time point will be undertaken. This will assist with guiding future dietetic practice regarding the use of predictive equations or the need for ongoing use of indirect calorimetry for optimal clinical care in this patient population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100702 0
Mrs Rochelle Kurmis
Address 100702 0
7G451
Royal Adelaide Hospital
Port Rd
Adelaide, SA
5000
Country 100702 0
Australia
Phone 100702 0
+61 8 7074 2503
Fax 100702 0
+61 8 7074 6224
Email 100702 0
Rochelle.Kurmis@sa.gov.au
Contact person for public queries
Name 100703 0
Mrs Rochelle Kurmis
Address 100703 0
7G451
Royal Adelaide Hospital
Port Rd
Adelaide, SA
5000
Country 100703 0
Australia
Phone 100703 0
+61 8 7074 2503
Fax 100703 0
+61 8 7074 6224
Email 100703 0
Rochelle.Kurmis@sa.gov.au
Contact person for scientific queries
Name 100704 0
Mrs Rochelle Kurmis
Address 100704 0
7G451
Royal Adelaide Hospital
Port Rd
Adelaide, SA
5000
Country 100704 0
Australia
Phone 100704 0
+61 8 7074 2503
Fax 100704 0
+61 8 7074 6224
Email 100704 0
Rochelle.Kurmis@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a small pilot study, and due to the nature (often reported in the media) and numbers of severe burn injuries treated, IPD will not be available. Due to the potential that this level of data may be able to be used to identify participants, this decision has been made in order to maintain participant confidentiality.
What supporting documents are/will be available?
No other documents available
Summary results
No Results