Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000356460
Ethics application status
Approved
Date submitted
1/07/2007
Date registered
3/07/2007
Date last updated
3/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The split thickness skin graft donor site; A comparative study of Tegaderm Absorbent and Kaltostat Alginate dressings
Scientific title
The split thickness skin graft donor site; A prospective randomised controlled trial that demonstrates improved rates of healing, reduced pain and superior ease of management with Tegaderm Absorbent in comparision to Kaltostat aliginate dressings.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Split thickness skin graft donor sites 1913 0
Condition category
Condition code
Skin 2004 2004 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparative study of 2 dressings - Contol dresssing; Kaltostat Alginate . New dressing on trial; Tegaderm Absorbent. . The first donor site dressing assessment is done 10-14 days postoperatively and subsequent dressings are done weekly thereafter till fully healed. Maximum duration 4 weeks / average duration 14 days.
Intervention code [1] 1865 0
Treatment: Surgery
Comparator / control treatment
Contol dresssing; Kaltostat Alginate.
Control group
Active

Outcomes
Primary outcome [1] 2828 0
Rate of Healing.
Timepoint [1] 2828 0
The first donor site dressing assessment is done 10 - 14 days postoperatively and subsequent dressings are done weekly thereafter till fully healed. Maximum duration 4 weeks / average duration 14 days.
Secondary outcome [1] 4773 0
Reduced pain
Timepoint [1] 4773 0
On day 1 & 2 postoperatively and with dressing changes (visual analogue scales 1-10).
Secondary outcome [2] 4774 0
Leakage from dressings
Timepoint [2] 4774 0
Observed in the first 2 weeks post surgery
Secondary outcome [3] 4775 0
Ease of Management
Timepoint [3] 4775 0
Patients questioned at their first dressing assessment as to difficulty with showering, walking etc.

Eligibility
Key inclusion criteria
All patients requiring a split thickness skin graft to be harvested from their thigh
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with allergies to Polyurethrane film dressings or Mefix tape.

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)
sequential patients requiring a skin graft on arriving in theatre are allocated a dressing according to the randomisation chart
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Monash Uni Statistician created a computer generated randomisation chart for us
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2148 0
Hospital
Name [1] 2148 0
Peninsular Health (Frankston Hospital)
Country [1] 2148 0
Australia
Primary sponsor type
Individual
Name
Patricia terrill
Address
Country
Secondary sponsor category [1] 1949 0
None
Name [1] 1949 0
nil
Address [1] 1949 0
Country [1] 1949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3943 0
Peninsula health-Peninsula private Hospital
Ethics committee address [1] 3943 0
Ethics committee country [1] 3943 0
Australia
Date submitted for ethics approval [1] 3943 0
Approval date [1] 3943 0
05/07/2006
Ethics approval number [1] 3943 0
TRIAL 2006-32

Summary
Brief summary
A trial has been carried out comparing a new dressing Tegaderm Absorbent with Kaltostat alginate dressing for use on the skin graft donor site.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27679 0
Address 27679 0
Country 27679 0
Phone 27679 0
Fax 27679 0
Email 27679 0
Contact person for public queries
Name 11054 0
Patricia Terrill
Address 11054 0
No 29 Specialist Centre
29 Hastings Road
Frankston 3199 (this is the best contact address)
OR
Frankston Hospital
PO Box 52 Frankston 3199
Country 11054 0
Australia
Phone 11054 0
+61 3 97696056 OR frankston hospital 97847777
Fax 11054 0
+61 3 97696057
Email 11054 0
n/a
Contact person for scientific queries
Name 1982 0
Patricia Terrill
Address 1982 0
No 29 Specialist Centre
29 Hastings road
Frankston 3199
Country 1982 0
Australia
Phone 1982 0
+61 3 97696056
Fax 1982 0
+61 3 97696057
Email 1982 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.