Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000150549
Ethics application status
Approved
Date submitted
25/04/2006
Date registered
2/05/2006
Date last updated
2/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skins>> Travel and Recovery (JetSkins™) Flight Trial 1001
Scientific title
A Randomized, Crossover, Open-Label Study of the Effectiveness of JetSkins™ in Reducing In-Flight Ankle Oedema
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Air travel induced ankle oedema 1122 0
Condition category
Condition code
Cardiovascular 1200 1200 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Skins>> Travel and Recovery compression garments (JetSkins™) ARTG ID: 80116 Class 1 Medical Device these are worn prior to take off and for the duration of the flight sector (minimum of 5 hours). There is a mimimum 48 hour washout period between flights.
Intervention code [1] 996 0
Prevention
Comparator / control treatment
The control is nil intervention for the duration of another minimum 5 hour flight sector.
Control group
Placebo

Outcomes
Primary outcome [1] 1628 0
Reduced ankle oedema - the difference between ankle circumference
Timepoint [1] 1628 0
measured at 0 hours and +5 hours
Secondary outcome [1] 2919 0
The difference between ankle circumference
Timepoint [1] 2919 0
Measured at 0 hrs and +2.5 hours.
Secondary outcome [2] 2920 0
Numerical rating scales + 5 hours after take off for pain, discomfort and swelling in legs, energy, alertness and concentration.
Timepoint [2] 2920 0
Post flight

Eligibility
Key inclusion criteria
Confirmed return flight booking with at least a 5 hour continuous sector in both directions.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of DVT Cardiovascular disease Coagulation disorders Varicose veins Bone or joint problems Diabetes Hypertension Obesity Neoplastic disease within previous 2 years except BCC.

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)
Sealed Envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence, simple randomisation i.e. no blocks or stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
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] 1313 0
Commercial sector/Industry
Name [1] 1313 0
Skins Compression Garments Pty Ltd
Country [1] 1313 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Skins Compression Garments Pty Ltd
Address
Suites 16-18, 171-179 Queen St
Campbelltown NSW 2560
Country
Australia
Secondary sponsor category [1] 1160 0
None
Name [1] 1160 0
Nil
Address [1] 1160 0
Country [1] 1160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2642 0
Bellberry Human Research Committee-Skins Compression Garments Pty Ltd
Ethics committee address [1] 2642 0
Ethics committee country [1] 2642 0
Australia
Date submitted for ethics approval [1] 2642 0
Approval date [1] 2642 0
12/04/2006
Ethics approval number [1] 2642 0
EC00372

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

Contacts
Principal investigator
Name 36087 0
Address 36087 0
Country 36087 0
Phone 36087 0
Fax 36087 0
Email 36087 0
Contact person for public queries
Name 10185 0
Steve Lambert
Address 10185 0
Skins Compression Garments Pty Ltd
Suites 16-18
171-179 Queen St
Campbelltown NSW 2560
Country 10185 0
Australia
Phone 10185 0
+61 2 46206555
Fax 10185 0
+61 2 42606999
Email 10185 0
stephen.lambert@skins.com.au
Contact person for scientific queries
Name 1113 0
Melissa Hagan
Address 1113 0
56 Lincoln Green Dr
Forestdale Q 4118
Country 1113 0
Australia
Phone 1113 0
+61 401 291 903
Fax 1113 0
+61 7 3800 4876
Email 1113 0
melissahagan@bigpond.com

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.