Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000092594
Ethics application status
Approved
Date submitted
28/02/2006
Date registered
9/03/2006
Date last updated
9/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the clinical effectiveness of Safetac soft silicone dressings in the management of skin tears
Scientific title
Evaluation of the effect of safetac soft silicone dressings on healing rates of skin tears, and impact on peri-wound skin
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hospital acquired skin tears 1056 0
Condition category
Condition code
Skin 1137 1137 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised prospective clinical trial. Safetac soft silicone coated dressings (Mepitel and Mepilex Border) after seven days of treatment.
Intervention code [1] 926 0
Treatment: Other
Comparator / control treatment
Standard treatment
Control group
Active

Outcomes
Primary outcome [1] 1522 0
Efficacy of treatment regimes on skin tear healing rates
Timepoint [1] 1522 0
At 7 days post treatment
Primary outcome [2] 1523 0
Efficacy of treatment regimes on peri-wound skin condition
Timepoint [2] 1523 0
At 7 days post treatment
Secondary outcome [1] 2760 0
Identify impact of dressing regimes on wound pain at dressing change.
Timepoint [1] 2760 0

Eligibility
Key inclusion criteria
A skin tear sustained during hospitalisation.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-admission skin tears non-consenting patientspatients with behavioural problems with which may interfere with the wound dressing protocol.

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)
Consecutively numbered sealed envelopes containing a randomly ordered treatment protocol (i.e., whilst the envelopes are in consecutive numerical order, the treatment protocols inside are in random order) will be placed in a secure box in each ward/unit. Staff will be required to sign a form next to the box with the envelope number, date and time to ensure the envelopes are removed in consecutive order and thus eliminating interference with the protocol randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1242 0
Government body
Name [1] 1242 0
Operating budget of Nursing Education & Research, Southern Health
Country [1] 1242 0
Australia
Primary sponsor type
Government body
Name
Nursing Education & Research, Southern Health
Address
Country
Australia
Secondary sponsor category [1] 1097 0
Commercial sector/Industry
Name [1] 1097 0
Tendra (Mölnlycke)
Address [1] 1097 0
Country [1] 1097 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2574 0
Southern Health HREC
Ethics committee address [1] 2574 0
Ethics committee country [1] 2574 0
Date submitted for ethics approval [1] 2574 0
Approval date [1] 2574 0
12/12/2005
Ethics approval number [1] 2574 0
05137A

Summary
Brief summary
To objectively evaluate the efficacy of Safetac soft silicone dressings compared with standard treatment, on skin tear healing rates. Also to measure the impact of wound dressings on the surrounding skin. It is expected that a significantly greater proportion of patient skin tears treated with soft silicone will be healed, without trauma to the surrounding skin, at 7 days when compared with the group receiving standard treatment
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35526 0
Address 35526 0
Country 35526 0
Phone 35526 0
Fax 35526 0
Email 35526 0
Contact person for public queries
Name 10115 0
Julie Baulch, Nurse Educator
Address 10115 0
Nursing Education and Research
Monash Medical Centre
Locked Bag 29
Clayton VIC 3168
Country 10115 0
Australia
Phone 10115 0
+61 3 95548399
Fax 10115 0
+61 3 95548776
Email 10115 0
[email protected]
Contact person for scientific queries
Name 1043 0
Cherene Kelly, Research Assistant
Address 1043 0
Nursing Education and Research
Monash Medical Centre
Locked Bag 29
Clayton VIC 3168
Country 1043 0
Australia
Phone 1043 0
+61 3 95947721
Fax 1043 0
+61 3 95946966
Email 1043 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.