Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000308493
Ethics application status
Approved
Date submitted
11/05/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Older adults with wounds: identifying nutritional risk, the magnitude of the problem and dietary factors influencing healing.
Scientific title
Older adults with wounds: using assessment tools to identify nutritional risk, the magnitude of the problem and dietary factors influencing healing.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing and nutritional status in Older Adults 1850 0
Condition category
Condition code
Diet and Nutrition 1944 1944 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Older adult inpatients with wounds at the Repatriation General Hospital (SA) will have their nutritional status assessed using the Mini-Nutritional Assessment (MNA), a validated and reliable nutrition assessment tool. In addition to this, participants will have their body composition measured using a Bioelectrical Impedance Assay (BIA), and their weight and height will be measured using standard protocols. The investigators will interview the participants to obtain information on their nutritional intake to enable comparisons to be made to recommendations for nutrition and wound healing. These measures will be repeated every 5-6 days during their hospital stay, to a maximum of 3 measurement intervals.
Patients with wounds at RGH have their wounds assessed by a registered nurse using standardised hospital-wide protocols. Data will be collected from the nursing documentation to allow the investigators to determine wound healing.
The BIA, MNA and the standardised interview (using the multiple replicate 24hr recall) are not currently practices of usual care. Currently, patients are assessed on an individual basis by a dietitian using a diet history or record of intake, compared with estimated nutritional requirements.
Intervention code [1] 1753 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 2763 0
Rate of Wound healing.
Timepoint [1] 2763 0
Wound size, depth and severity will be assessed on entry into the study and then every 5 days until discharge from the hospital, to a maximum of 3 measurements time points.
Secondary outcome [1] 4654 0
Nutritional status according to MNA score, BIA, body weight.
Timepoint [1] 4654 0
Each measurement will be collected on entry into the study, and then at 5 day intervals until discharge from hospital, or to a maximum of 3 time intervals.
Secondary outcome [2] 4655 0
Nutritional intake compared with requirements for wound healing
Timepoint [2] 4655 0
Assessed at study entry and then at 5 day intervals until discharge from hospital or to a maximum of 3 time intervals, and at discharge.

Eligibility
Key inclusion criteria
All older adults with wounds, who are inpatients within the Repatriation General Hospital.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative/terminal care patients, ICU patients, and patients receiving enteral or parenteral feeding.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2086 0
University
Name [1] 2086 0
Flinders University
Country [1] 2086 0
Australia
Funding source category [2] 2087 0
Hospital
Name [2] 2087 0
Repatriation General Hospital
Country [2] 2087 0
Australia
Primary sponsor type
Individual
Name
Jolene Thomas
Address
Country
Secondary sponsor category [1] 1892 0
Individual
Name [1] 1892 0
Dr Michelle Miller
Address [1] 1892 0
Country [1] 1892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3877 0
Repatriation General Hospital Research and Ethics Committee-Repatriation General Hospital
Ethics committee address [1] 3877 0
Ethics committee country [1] 3877 0
Australia
Date submitted for ethics approval [1] 3877 0
Approval date [1] 3877 0
24/04/2007
Ethics approval number [1] 3877 0
protocol 14/07

Summary
Brief summary
The main aim of this study is to identify nutritional issues that may impact nutritional status and on the healing on lower limb wounds or pressure ulcers in an inpatient population of Older Adults. A range of assessment methods will be utilised at designated time points during the participants' hospital admission. It is currently hypothesized that this group of patients are at an increased risk of under nutrition which may impact on the healing of their wounds. The results of this study will allow the investigators to identify the extent of nutritional issues within this group of patients, and some of the factors that may be contributing to undernutrition and poorer wound healing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27856 0
Address 27856 0
Country 27856 0
Phone 27856 0
Fax 27856 0
Email 27856 0
Contact person for public queries
Name 10942 0
Jolene Thomas
Address 10942 0
Department of Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001

Street Address:
Block G4
'The Flats'
Flinders University
Bedford Park SA 5041
Country 10942 0
Australia
Phone 10942 0
+61 8 82045863
Fax 10942 0
Email 10942 0
[email protected]
Contact person for scientific queries
Name 1870 0
Jolene Thomas
Address 1870 0
Department of Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001

Street Address:
Block G4
'The Flats'
Flinders University
Bedford Park SA 5041
Country 1870 0
Australia
Phone 1870 0
+61 8 82045863
Fax 1870 0
Email 1870 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.