Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000859583
Ethics application status
Approved
Date submitted
16/04/2015
Date registered
18/08/2015
Date last updated
18/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healing pressure ulcers/injuries: Efficacy and cost effectiveness of nutrition interventions in the treatment of pressure ulcer/injuries
Scientific title
Do specific nutrition interventions improve healing of pressure ulcer/injuries compared to standard nutritional care in hospital inpatients
Secondary ID [1] 286544 0
Nil
Universal Trial Number (UTN)
Trial acronym
NIPIHR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pressure ulcer/injury 294782 0
Condition category
Condition code
Skin 295064 295064 0 0
Other skin conditions
Diet and Nutrition 295147 295147 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomized to one of the following groups: a. Standard nutritional care by clinical team that may or may not include dietetic intervention, high protein/energy diet and/or nutritional supplement.
b. intensive individualised nutritional intervention provided by an associate investigator site dietitian aimed to meet estimated nutritional requirements of patients on a daily basis, which will likely include a high protein/energy diet and supplements (but not including wound healing supplements). Estimated nutritional requirements will be determined at 1.2g protein/kg and 30 KCal/kg per day. Patient will be reviewed by a dietitian for appox 20-30 minutes 3-4 times per week to assess intake and modify nutritional care plan if required.
c. standard care as described above, plus the provision of a nutritional supplements developed specifically to enhance wound healing ie complete oral liquid nutritional formulas enriched with Arginine, Vitamin C and Zinc. Supplements will be prescribed based on manufacturers recommendations ie 2 or 3 200-250ml tetrapaks daily. Patients will be given a choice of two different brands of supplements based on their preferences.

Supplement A contains per 200ml bottle: 20g protein (of which arginine is 3.0g), 250 KCal, 9 mg Zinc, 250 mg Vitamin C Recommended dose is 3 200ml bottles per day.
Supplement B contains per 250ml tetrapak: 21 g protein (of which arginine is 4.5g), 250 KCal, 15 mg Zinc, 250 mg Vitamin C. Recommended dose is 2 250 ml tetrapaks per day.

Duration of interventions will be for the duration of patient hospital stay.

Compliance with interventions will be monitored through data collection of food and fluid (including supplement) intake.
Intervention code [1] 291647 0
Treatment: Other
Comparator / control treatment
Standard nutritional care: standard clinical team based nutritional care that may include a dietetic or nutrition intervention such as high protein/energy diet and/or nutritional supplements.
Control group
Active

Outcomes
Primary outcome [1] 294829 0
Mean change in pressure injury measured in 2 different way: 1. surface area - measured using Visitrak wound measurement system by trained Research Assistant
2. severity score - measured using Pressure Ulcer Scale for Healing PUSH Score - by trained Research Assistant.
Timepoint [1] 294829 0
Day 14
Primary outcome [2] 294830 0
Days to healing - measured as number of days from randomization into study until full wound closure.
Timepoint [2] 294830 0
30 days
Primary outcome [3] 294913 0
Cost effectiveness of nutritional interventions in pressure ulcer healing. This will be measured by incremental cost-effectiveness ratio of alternate nutrition interventions compared to other forms of treatment of pressure ulcer.
Timepoint [3] 294913 0
30 days
Secondary outcome [1] 314174 0
Number of pressure ulcers healed between groups - measured by number of pressure ulcers in each study group healed until full wound closure
Timepoint [1] 314174 0
30 days
Secondary outcome [2] 314327 0
Acceptability and adherence to nutritional interventions between groups. This will be measured by determining quantifying nutritional intake from 24 hour food and supplement records; patient complications eg. gastrointestinal side effects and patient satisfaction feedback.
Timepoint [2] 314327 0
Duration of intervention.

Eligibility
Key inclusion criteria
Inpatients (adults) of 5 acute hospitals with pressure ulcer/injury stage 2 or greater.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage 1 of deep tissue pressure injury
Patients unable to receive nutrition via enteral route
Patients inappropriate for intensive nutrition support ie palliative care
Patients unable to follow nutrition support advise ie cognitively impaired
Pregnancy
Previously recruited to study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients in consecutive order as identified by clinical staff will be approach for consent to participate in study.
Consenting patients will be randomly assigned to treatment groups by independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratified by severity of pressure ulcer based on PUSH score
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2013
Actual
10/01/2013
Date of last participant enrolment
Anticipated
30/05/2014
Actual
30/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
285
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291110 0
Government body
Name [1] 291110 0
NHMRC
Country [1] 291110 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Butterfield St
HERSTON 4029 QLD
Country
Australia
Secondary sponsor category [1] 289786 0
University
Name [1] 289786 0
University of Queensland
Address [1] 289786 0
Sir Fred Schonnel Drive
St Lucia 4067 QLD
Country [1] 289786 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292689 0
Royal Brisbane & Women's HREC
Ethics committee address [1] 292689 0
Ethics committee country [1] 292689 0
Australia
Date submitted for ethics approval [1] 292689 0
Approval date [1] 292689 0
08/06/2012
Ethics approval number [1] 292689 0
HREC/12/QRBW/125

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56590 0
Dr Merrilyn Banks
Address 56590 0
Nutrition & Dietetics
Royal Brisbane & Women's Hospital
Butterfield St
HERSTON 4029 QLD
Country 56590 0
Australia
Phone 56590 0
617 36467994
Fax 56590 0
Email 56590 0
[email protected]
Contact person for public queries
Name 56591 0
Merrilyn Banks
Address 56591 0
Nutrition & Dietetics
Royal Brisbane & Women's Hospital
Butterfield St
HERSTON 4029 QLD
Country 56591 0
Australia
Phone 56591 0
617 36467994
Fax 56591 0
Email 56591 0
[email protected]
Contact person for scientific queries
Name 56592 0
Merrilyn Banks
Address 56592 0
Nutrition & Dietetics
Royal Brisbane & Women's Hospital
Butterfield St
HERSTON 4029 QLD
Country 56592 0
Australia
Phone 56592 0
617 36467994
Fax 56592 0
Email 56592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.