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Trial registered on ANZCTR


Registration number
ACTRN12611000349943
Ethics application status
Approved
Date submitted
28/03/2011
Date registered
4/04/2011
Date last updated
15/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does treatment with an intensive and specific nutritional intervention improve pressure ulcer healing compared to standard nutritional care? A pilot study.
Scientific title
Do inpatients with pressure ulcer receiving intensive and specific nutritional care have improved healing compared with standard nutritional care?
Secondary ID [1] 259867 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pressure ulcer 265455 0
Condition category
Condition code
Skin 265611 265611 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive and specific nutritional care, including prescribed diet to achieve 1.5-2g protein/Kg/day and 30-35 KCal/Kg/day; including recommended consumption of 2-3 tetrapaks of specialized nutritional formulae - enriched with arginine, Vitamin C and Vitamin A. Review by intervention Dietitian 4-5 times per week of 15-30 minutes to monitor intake and adjust diet to maximise nutritional intake. Up to period of 4 weeks, or until discharge or healing of PU.
Intervention code [1] 264288 0
Treatment: Other
Comparator / control treatment
Standard nutritional care includes current nutritional care provided by treating team, including a dietitian. This may vary from the patient receiving only a standard hospital diet and not being referred to a dietitian, to being prescribed a high protein/energy diet and being reviewed by a dietitian regularly. Patients receiving standard nutritional care may be prescribed nutritional supplements, but not the specialized nutritional formulae enriched with arginine, Vitamin A and C.
Control group
Active

Outcomes
Primary outcome [1] 262395 0
mean change in surface area of pressure ulcer between groups as measured by VISITRAK wound measurement system and PUSH (Pressure ulcer scale for healing) Tool.
Timepoint [1] 262395 0
at 15, 20, 25 and 30 days after randomization, or until discharged or healed
Secondary outcome [1] 273694 0
Mean difference in protein and energy intake between groups, as assessed from food intake records collected on data collection days of day 0,5,10,15,20,25,30 and analysed using FoodWorks nutritional analysis software.
Timepoint [1] 273694 0
at 15, 20, 25 and 30 days after randomization or until discharged or healed
Secondary outcome [2] 273695 0
Cost comparison of treatment between two groups. This will be determined from the organisation's perspective and data collected includes: The mean difference in cost between the 2 groups will be determined for: nutritional supplements, intervention staff time, patient length of hospital stay.
Timepoint [2] 273695 0
across intervention

Eligibility
Key inclusion criteria
Inpatients of the Royal Brisbane & Women's hospital diagnosed with recent onset (within 1 month) stage II, III or IV pressure ulcer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to receive nutrition support via enteral route (oral or tube); patients receiving palliative care; patients with cognitive impairment.

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 will be advised of the study by ward nurses or Skin Integrity Nurses and asked if they wish to participate. If the patient agrees, the Research Nurse is notified and then undertakes consent to participate in the study with the patient. Upon consent the Research Nurse notifies the Study Coordinator, who in turn refers to computer generated randomizer, and notifies Research Dietitian of the randomization outcome. Allocation occurs after consent and involves contacting the holder of the allocation schedule at a central administration location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
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
5/10/2010
Actual
5/10/2010
Date of last participant enrolment
Anticipated
31/03/2011
Actual
28/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264744 0
Government body
Name [1] 264744 0
Queensland Health
Country [1] 264744 0
Australia
Primary sponsor type
Government body
Name
Allied Health Workforce Advisory and Coordination Unit
Address
Charlotte St
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 263868 0
Hospital
Name [1] 263868 0
Royal Brisbane & Women's Hospital
Address [1] 263868 0
Butterfield St
HERSTON QLD 4029
Country [1] 263868 0
Australia
Other collaborator category [1] 251899 0
University
Name [1] 251899 0
Queensland University of Technology
Address [1] 251899 0
IHBI
Musk Ave
KELVIN GROVE QLD 4059
Country [1] 251899 0
Australia
Other collaborator category [2] 251900 0
University
Name [2] 251900 0
Queensland University of Technology
Address [2] 251900 0
Victoria Park Road
KELVIN GROVE QLD 4059
Country [2] 251900 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266729 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 266729 0
Butterfield St
HERSTON QLD 4029
Ethics committee country [1] 266729 0
Australia
Date submitted for ethics approval [1] 266729 0
Approval date [1] 266729 0
21/07/2010
Ethics approval number [1] 266729 0
HREC/10/QRBW/240

Summary
Brief summary
This study intends to investigate if there is any improvement in healing of pressure ulcer in hospitalized patients receiving an intensive and specialized nutrition intervention compared to standard nutritional care. This pilot study is being conducted initially to determine if the nutrition intervention is feasible, how many patients can be enrolled and if the nutrition intervention improves healing. This data will assist in planning future, larger studies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32396 0
Dr Merrilyn Banks
Address 32396 0
Royal Brisbane & Women's Hospital
Butterfield St
HERSTON QLD 4029
Country 32396 0
Australia
Phone 32396 0
617 36467994
Fax 32396 0
Email 32396 0
[email protected]
Contact person for public queries
Name 15643 0
Merrilyn Banks
Address 15643 0
Nutrition & Dietetics
Royal Brisbane & Women's Hospital
HERSTON QLD 4029
Country 15643 0
Australia
Phone 15643 0
+61 7 3636 7994
Fax 15643 0
Email 15643 0
[email protected]
Contact person for scientific queries
Name 6571 0
Merrilyn Banks
Address 6571 0
Nutrition & Dietetics
Royal Brisbane & Women's Hospital
HERSTON QLD 4029
Country 6571 0
Australia
Phone 6571 0
+61 7 36367994
Fax 6571 0
Email 6571 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.