RecruitingACTRN12620000388910

Understanding nutritional requirements of severe burn injury patients treated with a new skin substitute by directly measuring their individual energy expenditure.

Determination of nutritional requirements for severe burn injury patients requiring application of Novosorb® BTM using indirect calorimetry: a pilot study


Sponsor

Royal Adelaide Hospital

Enrollment

8 participants

Start Date

Jul 13, 2020

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Severe burn injuries — those covering 20% or more of the body — place enormous demands on the body, and getting nutrition right during recovery is critical. A newer type of wound covering called Novosorb BTM (Biodegradable Temporising Matrix) is now being used in Australian burns units to help prepare wounds for skin grafting, but we don't yet know how much energy the body needs specifically while this product is in place. This study measures the actual energy expenditure of severe burn patients who have received BTM, using a gold-standard technique called indirect calorimetry (measuring oxygen and carbon dioxide in breathed air). Measurements are taken at multiple points before and after surgery. This information is then compared to the predictions from standard formulas to see how accurate those formulas are in this specific population, helping dietitians prescribe the right amount of nutrition. You may be eligible if you are an adult (18 or older) admitted to the Royal Adelaide Hospital burns unit with severe burns covering at least 20% of your body surface area and requiring BTM application. Severe head injury, inborn errors of metabolism, claustrophobia, or inability to consent would make you ineligible.

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Interventions

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 e

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.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12620000388910