Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000210976
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
20/02/2020
Date last updated
20/02/2020
Date data sharing statement initially provided
20/02/2020
Date results information initially provided
20/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using moisturiser to reduce the number of skin-tear injuries in a hospital setting.
Scientific title
Twice-daily skin moisturising to reduce the incidence of skin tears in an acute hospital setting.
Secondary ID [1] 300147 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin tear 315677 0
Condition category
Condition code
Skin 313966 313966 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twice-daily application to the arms and legs of Hartmann, MoliCare® skin and body lotion with active ingredient of: creatine, essential fatty acids, amino acids and almond oil. Supports the skins own protection mechanisms and is moisturising. Water-in-oil emulsion.
The lotion is applied by a registered nurse working in the clinical setting and incorporating this modality into their daily routine of patient care. The lotion is applied at two 10 minute lotions applications per day - once in the am and once in the PM.
The intervention will not be personalised, titrated or adapted - each individual enrolled in the intervention arm of the study will receive twice daily application of moisturiser to the upper and lower limbs.
The clinician documents that they have applied the moisturiser on the patients body by way of the - Skin Tear Clinical Trial: Moisturiser Application Chart.
Intervention code [1] 316418 0
Treatment: Other
Comparator / control treatment
An experimental and a control ward in a large hospital in regional Victoria were identified as equivalent both in terms of demography and patient acuity.
The experimental ward (rehabilitation) and the control ward (medical / oncology ward).
Patients admitted to the two wards who were 70 years of age or over, who were not being admitted for surgery and had no allergy to nuts were invited to participate.
The medical/oncology ward provided the control with no intervention introduced to that clinical setting for the management or reduction of skin tears beyond the routine care provided. .
Control group
Active

Outcomes
Primary outcome [1] 322375 0
Change in the number of skin tears as assessed by registered nurses against the Skin Tear Audit Research Classification (STAR) data linkage to RISKMan incident database.
Timepoint [1] 322375 0
At one month after randomisation
Secondary outcome [1] 378254 0
Change in the number of skin tears as assessed by registered nurses against the Skin Tear Audit Research Classification (STAR) data linkage to RISKMan incident database.
Timepoint [1] 378254 0
At 12 months after randomisation

Eligibility
Key inclusion criteria
Participants eligible for inclusion were those: equal to or greater than 70 years of age, their admission did not require surgery, the patient reported to have no known allergy to nuts.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants excluded from the study were those: not equal to or greater than 70 years of age, the patient reported an allergy to nuts.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Kruskal-Wallis Test as well as a Mann-Whitney U Test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/08/2016
Date of last participant enrolment
Anticipated
Actual
30/11/2016
Date of last data collection
Anticipated
Actual
30/06/2019
Sample size
Target
100
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15703 0
St John of God Hospital, Ballarat - Ballarat
Recruitment postcode(s) [1] 29124 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 304583 0
University
Name [1] 304583 0
Federation University
Country [1] 304583 0
Australia
Funding source category [2] 304586 0
Hospital
Name [2] 304586 0
St John of God (Ballarat)
Country [2] 304586 0
Australia
Primary sponsor type
Hospital
Name
St John of God (Ballarat)
Address
St John of God Healthcare,
101 Drummond St N, Ballarat VIC 3350
Country
Australia
Secondary sponsor category [1] 304871 0
University
Name [1] 304871 0
Federation University
Address [1] 304871 0
Federation University, PO Box 663, Ballarat, Victoria, 3353
Country [1] 304871 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305009 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 305009 0
12 Salvado Road, Subiaco, WA, 6008,
PO Box 14 Subiaco, WA, 6904
Ethics committee country [1] 305009 0
Australia
Date submitted for ethics approval [1] 305009 0
20/05/2016
Approval date [1] 305009 0
26/06/2016
Ethics approval number [1] 305009 0
977

Summary
Brief summary
A case-control design was used to examine the use of Hartmann, MoliCare® skin and body lotion to reduce skin tears among patients between two wards in an Australian private hospital. The two wards identified for the study was a medical/oncology ward which provided the control and the rehabilitation ward where the intervention was instituted. These two settings are considered comparable on the basis of patient demography as well as the level of patient acuity. Longitudinal data were collected for these settings both pre and post intervention period to determine the treatment’s efficacy and impact.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98950 0
Dr Blake Peck
Address 98950 0
Federation University,
School of Nursing and Healthcare Professions
PO Box, 663, MtHelen, Ballarat, Victoria, 3353
Country 98950 0
Australia
Phone 98950 0
+61 3 5327 9097
Fax 98950 0
Email 98950 0
[email protected]
Contact person for public queries
Name 98951 0
Dr Blake Peck
Address 98951 0
Federation University,
School of Nursing and Healthcare Professions
PO Box, 663, MtHelen, Ballarat, Victoria, 3353
Country 98951 0
Australia
Phone 98951 0
+61 3 5327 9097
Fax 98951 0
Email 98951 0
[email protected]
Contact person for scientific queries
Name 98952 0
Dr Blake Peck
Address 98952 0
Federation University,
School of Nursing and Healthcare Professions
PO Box, 663, MtHelen, Ballarat, Victoria, 3353
Country 98952 0
Australia
Phone 98952 0
+61 3 5327 9097
Fax 98952 0
Email 98952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The identification of individual data is unnecessary for the purpose of the primary outcome measure of this project. In light of this, we did not apply for ethical approval for this.


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.