Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000941268
Ethics application status
Approved
Date submitted
21/10/2009
Date registered
3/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sub bandage pressures of straight tubular three layer (3L) bandages and short stretch (SS) bandage in healthy volunteers.
Scientific title
An open label, prospective single factor crossover design to measure and compare the sub bandage pressures of a graduated three layer straight tubular (3L) bandaging system and standard short stretch (SS) compression bandaging system in healthy volunteers.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous leg ulcers 252042 0
Condition category
Condition code
Skin 252232 252232 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3L (elastic) Tubular bandaging was used in three graduated lengths of 3 layers as follows:
1. from base of toes to just under knee (long layer)
2. from base of toes to above calf pump (medium layer)
3. from base of toes to mid gaiter (short layer)
This study is a within person sub bandage comparison.Participants will have an elastic bandage applied to one limb and the inelastic bandage applied to the other limb. All layers will be applied at the same time and measured with a sub bandage pressure measurement instrument. Participant legs randomised to either control compression bandage or to the intervention compression bandage. Eg. right leg randomised to control or intervention bandage. The overall duration of this trial is one day. There is no washout period.
Intervention code [1] 241439 0
Other interventions
Comparator / control treatment
SS (Inelastic): Standard short stretch compression therapy consists of:
1. A padding layer
2. 10cm inelastic short stretch compression bandage
3. A tubular support bandage
All layers of standard compression therapy were applied from base of toes to just under the knee. All layers applied at same time. Participant legs will be randomised to either control compression bandage or to the intervention compression bandage. Eg. right leg randomised to control or intervention bandage The overall duration of this trial is one day.
Control group
Active

Outcomes
Primary outcome [1] 253101 0
To estimate the magnitude of difference in mean sub-bandage pressure of 3L (elastic) and SS (inelastic) compression bandage systems at rest, standing , exercise and recovery.
Timepoint [1] 253101 0
Six quantitative outcome measures were defined between the two bandage systems: (i)-(iv) the difference in mean sub-bandage pressure during each of four activities; (v) the difference in stiffness parameter ; and (vi) the difference in amplitude of sub -bandage pressure (SBP) during the exercise activity. The outcome was measured during the intervention at 0.25 second intervals for entire 90 seconds for each participant.
Primary outcome [2] 253103 0
To estimate the difference in mean stiffness parameter (SP) between bandage types.
To estimate the difference in mean amplitude of sub-bandage pressure during exercise between bandage systems.
The outcome was measured during the intervention at 0.25 second intervals for entire 90 seconds for each participant.
Timepoint [2] 253103 0
Six quantitative outcome measures were defined between the two bandage systems: (i)-(iv) the difference in mean sub-bandage pressure during each of four activities; (v) the difference in stiffness parameter ; and (vi) the difference in amplitude of SBP during the exercise activity.
The outcome was measured during the intervention at 0.25 second intervals for entire 90 seconds for each participant.
Primary outcome [3] 253104 0
To estimate the difference in mean amplitude of sub-bandage pressure during exercise between bandage systems.
The outcome was measured during the intervention at 0.25 second intervals for entire 90 seconds for each participant.
Timepoint [3] 253104 0
Six quantitative outcome measures were defined between the two bandage systems: (i)-(iv) the difference in mean sub-bandage pressure during each of four activities; (v) the difference in stiffness parameter ; and (vi) the difference in amplitude of SBP during the exercise activity
Secondary outcome [1] 257973 0
NIL
Timepoint [1] 257973 0
NIL

Eligibility
Key inclusion criteria
Aged over 18
Have a palpable dorsalis pedis pulse
Ankle circumference equal to or greater than 20 cm and less than 30 cm on both legs
Ambulant
Able to give Informed Consent
Able to understand and comply with the requirements of the trial
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any lesions on either lower limb

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was stratified by person. One of each type of bandage (elastic or inelastic) was randomised to either right or left leg for each participant. Randomisation followed a computer generated allocation schedule to ensure that elastic and inelastic bandages were allocated equally between right and left legs in each participant. Participants were unaware of prior treatment assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence randomisation was achieved by using a computer generated algorithm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
An open-label, prospective single factor crossover randomised clinically controlled trial.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243910 0
University
Name [1] 243910 0
Monash UNiversity
Country [1] 243910 0
Australia
Primary sponsor type
Individual
Name
Carolina Weller
Address
Department of Epidemiology & Preventive Medicine
Monash University

School of Public Health & Preventive Medicine
The Alfred, Melbourne, Vic 3004
Australia

3rd floor, Burnet Tower
89 Commercial Rd, Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 251255 0
None
Name [1] 251255 0
Address [1] 251255 0
Country [1] 251255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244024 0
Monash University Standing Committee on Ethics in Research involving Humans (SCERH)
Ethics committee address [1] 244024 0
Monash University
Building 3E Clayton campus
Wellington road Clayton
VIC 3800
Ethics committee country [1] 244024 0
Australia
Date submitted for ethics approval [1] 244024 0
23/03/2009
Approval date [1] 244024 0
26/03/2009
Ethics approval number [1] 244024 0
2009000388

Summary
Brief summary
To compare the interface sub-bandage pressure between two multilayer compression bandage systems during supine position, standing, exercise and recovery.
Alternate hypothesis: The difference between mean Sub bandage pressure of elastic and inealstic bandage compression systems exceeds 10 mmHg.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30406 0
Address 30406 0
Country 30406 0
Phone 30406 0
Fax 30406 0
Email 30406 0
Contact person for public queries
Name 13653 0
carolina weller
Address 13653 0
Department of Epidemiology & Preventive Medicine
Monash University

School of Public Health & Preventive Medicine
The Alfred, Melbourne, Vic 3004
Australia

3rd floor, Burnet Tower
89 Commercial Rd, Melbourne, Vic 3004
Country 13653 0
Australia
Phone 13653 0
+61 03 99030623
Fax 13653 0
Email 13653 0
carolina.weller@med.monash.edu.au
Contact person for scientific queries
Name 4581 0
carolina Weller
Address 4581 0
Department of Epidemiology & Preventive Medicine
Monash University

School of Public Health & Preventive Medicine
The Alfred, Melbourne, Vic 3004
Australia

3rd floor, Burnet Tower
89 Commercial Rd, Melbourne, Vic 3004
Country 4581 0
Australia
Phone 4581 0
+61 03 99030623
Fax 4581 0
Email 4581 0
carolina.weller@med.monash.edu.au

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
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