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Trial registered on ANZCTR


Registration number
ACTRN12610000399099
Ethics application status
Approved
Date submitted
17/05/2010
Date registered
18/05/2010
Date last updated
2/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, randomised trial to compare pain and healing between skin-graft donor site dressings: Duoderm vs AWBAT-D.
Scientific title
A prospective, randomised trial to compare time to healing and pain experienced during healing between two different skin-graft donor site dressings: Duoderm vs AWBAT-D.
Secondary ID [1] 251781 0
nil
Universal Trial Number (UTN)
U1111-1115-0432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain suffered during healing of split-skin graft donor sites. Length of time for these iatrogenically created wounds to heal (has implications for serial wound repair in major burn injury >50% Total Body Surface Area (TBSA). 257376 0
Condition category
Condition code
Injuries and Accidents 257524 257524 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An appraisal of the two main outcomes in donor-site management (pain and time to healing) using two different dressings. Duoderm (a hydrocolloid and the current treatment of these wounds in our centre) and AWBAT-D (a new biosynthetic skin substitute specifically designed to expedite healing of these wounds). AWBAT-D consists of a wound surface of woven nylon matrix to which procine type 1 collagen fragments are bonded (matt), with a porous silicone outer surface (shiny). AWBAT-D is applied matt side down, shiny side up. The material is overdressed with Acticoat nanocrystalline silver polyester dressing. AWBAT-D remains in situ until healing occurs when it detaches spontaneously after 10-14 days. If one patient has two donor sites which allow them to be their own control (ie both materials will be applied, one to each site), the site to receive AWBAT-D is allocated by randomisation table. Duoderm is applied to the other site (adhesive side to wound). There is always sufficient gap between the materials to prevent cross-contamination by wound exudate
Intervention code [1] 256483 0
Treatment: Other
Comparator / control treatment
The control dressing is Duoderm (specified above). This hydrocolloid is the current dressing for donor sites on our unit. Most patients (single small donor sites) are randomised to receive one or the other dressing. Large donor sites can be randomised to allow the patient to be their own control also. Duoderm has an adhesive side which is applied to the wound surface. Repeated changes of Duoderm are usually required since the hydrocolloid intreaction with wound exudate creates a thick yellow fluid and Duoderm's impermeability means that this fluid stays under the dressing (until it leaks out from the sides and soaks the outer dressings). Duoderm change frequency is determined by clinical need, not at set toimepoints, and will generally require 3 - 6 changes before healing occurs in 14 - 21 days.
Control group
Active

Outcomes
Primary outcome [1] 258440 0
Discomfort experienced during healing (whether intrinsic to the wound, pain with dressing changes, pain with therapy/mobilisation). This is assessed by a pain score (vocalised analog score) 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Timepoint [1] 258440 0
Daily from application until healing (expected within 14 days)
Secondary outcome [1] 264223 0
Time to re-epithelialisation of donor-site.
Timepoint [1] 264223 0
Daily from application until healing (expected within 14 days). Epithelialisation can be said to occur when the 'finely wrinkled' shiny, dry appearance of neo-epithelialisation is seen to cover the entire wound as opposed to the wet, shiny unhealed areas.

Eligibility
Key inclusion criteria
Split-skin graft donor sites
Two non-contiguous donor sites of the same approximate size for comparison (patient own control),
OR
One donor site to receive either AWBAT-D dressing OR Duoderm dressing
Patient Age: 18 - 70 years
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy/Lactation
Ventilated patients (no consent)
Non-English speakers (from an informed consent perspective)
Co-morbidity which may compromise healing
Known allergy to porcine products or religious issues with such products

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)
Allocation table has been produced using computer-generated random numbers for those with 1 donor site kept in sealed opaque envelopes.

Allocation table has been produced using computer-generated random numbers kept in sealed opaque envelopes for those with 2 donor sites which allocates AWBAT-D to medial/left or lateral/right and either proximal or distal sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2010
Actual
6/05/2010
Date of last participant enrolment
Anticipated
Actual
22/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256975 0
Hospital
Name [1] 256975 0
Royal Adelaide Hospital
Country [1] 256975 0
Australia
Primary sponsor type
Individual
Name
Dr John E Greenwood AM
Address
Burns Unit,
Royal Adelaide Hospital
North Terrace,
Adelaide,
South Australia 5000,
Australia
Country
Australia
Secondary sponsor category [1] 256235 0
Hospital
Name [1] 256235 0
Royal Adelaide Hospital
Address [1] 256235 0
Royal Adelaide Hospital
North Terrace,
Adelaide,
South Australia 5000,
Australia
Country [1] 256235 0
Australia
Other collaborator category [1] 1258 0
Individual
Name [1] 1258 0
Dr Ian P Mackie
Address [1] 1258 0
Burns Unit,
Royal Adelaide Hospital
North Terrace,
Adelaide,
South Australia 5000,
Australia
Country [1] 1258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258989 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 258989 0
Level 3, Hanson Institute,
Royal Adelaide Hospital
North Terrace,
Adelaide,
South Australia 5000,
Australia
Ethics committee country [1] 258989 0
Australia
Date submitted for ethics approval [1] 258989 0
Approval date [1] 258989 0
05/05/2010
Ethics approval number [1] 258989 0
100413

Summary
Brief summary
The purpose of this research study is to compare the rate of healing and your perception of pain associated with the treatment of your skin graft donor site. The donor site is the wound left behind when a skin graft has been taken. It is frequently a very uncomfortable wound which usually heals by itself in 10-14 days. Two different types of dressing are being studied. One dressing is currently used typically for donor site care in burn patients on the Burns Unit at the Royal Adelaide Hospital (Duoderm®). This dressing is approved by the Therapeutic Goods Administration for sale and use in Australia. AWBAT-D™ is approved by the Federal Drugs Administration for use and sale in the United States, but in Australia can only be used currently as part of a clinical trial (like this one). The decision regarding which dressing you will receive will be 'random'. If you require two separate donor sites, both materials will be used (one on each site.
Trial website
Trial related presentations / publications
Solanki NS, Mackie IP, Greenwood JE. 'A randomized prospective study of split-skin graft donor site dressings: AWBAT-D vs. Duoderm' Burns September 2012;38(6):889-898.
Public notes

Contacts
Principal investigator
Name 31169 0
A/Prof John E Greenwood
Address 31169 0
Adult Burn Service, Royal Adelaide Hospital, North Terrace, Adelaide 5000, South Australia
Country 31169 0
Australia
Phone 31169 0
+61 8 8222 2233
Fax 31169 0
+61 8 8222 5676
Email 31169 0
[email protected]
Contact person for public queries
Name 14416 0
John E Greenwood
Address 14416 0
Burns Unit, Royal Adelaide Hospital,
North Terrace, Adelaide
South Australia 5000,
Australia
Country 14416 0
Australia
Phone 14416 0
+61 8 8222 2233
Fax 14416 0
+61 8 8222 5676
Email 14416 0
[email protected]
Contact person for scientific queries
Name 5344 0
John E Greenwood
Address 5344 0
Burns Unit, Royal Adelaide Hospital,
North Terrace, Adelaide
South Australia 5000,
Australia
Country 5344 0
Australia
Phone 5344 0
+61 8 8222 2233
Fax 5344 0
+61 8 8222 5676
Email 5344 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

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