Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000496314
Ethics application status
Approved
Date submitted
31/07/2008
Date registered
30/09/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of prolonged taping of scars to improve their appaerance following surgery
Scientific title
Does taping wounds on the trunk post-operatively reduce wound spread and increase patient satisfaction with the scar?
Secondary ID [1] 728 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Appearance of post-operative scars on the trunk 3496 0
Condition category
Condition code
Other 3650 3650 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tapes applied to wound immediately after surgery and for 12 weeks therafter. Patients are required to change tapes once per week or sooner if they become loose or soiled. We are using 10mm x100mm "leukostrips" which are manufactured by Smith & Nephew
Intervention code [1] 3217 0
Treatment: Devices
Comparator / control treatment
Identical surgical technique (including closure with deep and superficial sututres) but no tapes applied to wound post-operatively
Control group
Active

Outcomes
Primary outcome [1] 4553 0
Width and general appaerance of scar (measured by a blinded assessor)
Timepoint [1] 4553 0
3 and 6 months following surgery
Secondary outcome [1] 7703 0
Patient satisfaction with appaerance of scar. The Likert scale will be used
Timepoint [1] 7703 0
3 and 6 months following surgery

Eligibility
Key inclusion criteria
Minor surgery to skin on torso that would result in a wound of at least 8mm.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1)Lesions on the back where there is no-one available to help with tape application
2) Physical disability that would restrict ability to comply with the intervention
3)Mental disability preventing informed consent
4)Chronic cough
5)Concurrent use of immunosupreesive drugs
6)Known tendency to keloid scarring
7)Known allergy to sutures, tapes or dressings to be used for study
8)Flap surgery
9)Excision of subcutaneous lesions

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)
All eligible patients requiring surgery to the torso informed of study during consultation prior to surgery appointment. Informed consent signed by those wishing to partake in study. Sequentially numbered (corresponding to participant study number)sealed opaque envelopes containing details of intervention or control group allocation only opened after the surgery has been completed. Thus the doctor and staff are all blinded to patient study group until after surgical intervention completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence of study group allocation done in blocks of six. Details of study group allocation sealed in sequentially numbered opaque envelopes within the Department of General Practice, University of Queensland prior to patient recruitment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
204
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3668 0
Government body
Name [1] 3668 0
Primary Health Care Research and Development (PHCRED)
Country [1] 3668 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Skin Alert
Address
PO Box 6972
Tweed heads
NSW 2486
Country
Australia
Secondary sponsor category [1] 3295 0
None
Name [1] 3295 0
Address [1] 3295 0
Country [1] 3295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6004 0
Human ethics
Ethics committee address [1] 6004 0
Ethics committee country [1] 6004 0
Australia
Date submitted for ethics approval [1] 6004 0
Approval date [1] 6004 0
15/05/2008
Ethics approval number [1] 6004 0
#2008000535

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

Contacts
Principal investigator
Name 28801 0
Address 28801 0
Country 28801 0
Phone 28801 0
Fax 28801 0
Email 28801 0
Contact person for public queries
Name 11958 0
Dr Helena Rosengren
Address 11958 0
Skin Alert
149 charters towers Rd
Hyde Park
QLD 4812
Country 11958 0
Australia
Phone 11958 0
07 47250473
Fax 11958 0
07 47251937
Email 11958 0
[email protected]
Contact person for scientific queries
Name 2886 0
Dr Helena Rosengren
Address 2886 0
Skin Alert
149 charters towers Rd
Hyde Park
QLD 4812
Country 2886 0
Australia
Phone 2886 0
07 47250473
Fax 2886 0
07 47251937
Email 2886 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.