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Trial registered on ANZCTR


Registration number
ACTRN12614000473662
Ethics application status
Approved
Date submitted
15/02/2014
Date registered
6/05/2014
Date last updated
6/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Double-blinded Prospective Randomised Controlled Trial of Split Skin Graft Donor-Site Dressing: Altrazeal vs. Kaltostat
Scientific title
Double-blinded Prospective Randomised Controlled Trial of Split Skin Graft Donor-Site Dressing: A Clinical Comparative Trial of a Novel Transforming Powder Dressing, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) Dressing.
Secondary ID [1] 284103 0
Nil
Universal Trial Number (UTN)
U1111-1153-1695
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dressing of split skin graft donor sites which are secondary skin defects created as a result of having to reconstruct skin defects after excision of skin neoplasm, burns, infection, trauma or other dermatological conditions 291179 0
Condition category
Condition code
Surgery 291518 291518 0 0
Other surgery
Skin 292162 292162 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Novel Transforming Powder Dressing, Altrazeal (TM), is a dressing type that comes in powder form, which is immediately applied onto the thigh after split skin graft had been harvested. It is then dressed with secondary dressings including gauze and mefix. All dressings are left intact for at least 2 weeks until reviewed in outpatient clinic. It is a once-only dressing which will not require a repeat application unless the initial dressings comes off prematurely as a result of significant haematoma.
Intervention code [1] 288798 0
Treatment: Devices
Comparator / control treatment
Calcium Sodium Alginate, Kaltostat (TM), is a is a dressing type that comes in a broad sheet form, which is immediately applied onto the thigh after split skin graft had been harvested. It is then dressed with secondary dressings including gauze and mefix. All dressings are left intact for at least 2 weeks until reviewed in outpatient clinic. It is a once-only dressing which will not require a repeat application unless the initial dressings comes off prematurely as a result of significant haematoma.
Control group
Active

Outcomes
Primary outcome [1] 291488 0
Patient’s experience of pain arising from donor sites from postoperative day 2 - 5, and day 14 using a Visual Analogue Scale (VAS).
Timepoint [1] 291488 0
Postoperative day 2 - 5, and day 14
Secondary outcome [1] 306887 0
Rate of wound healing at the donor site dressed with Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM), measured by the proportion (percentage) of healed wound out of the total DSW surface upon assessment on postoperative day 14. “Healed wound” defined as re-epithelialized wound surface (i.e. no areas of exudates/scabs).
Timepoint [1] 306887 0
Postoperative day 14.
Secondary outcome [2] 307951 0
Rate of donor-site wound infection for each product. Diagnosis of wound infection is based on clinical symptoms of erythema, increasing pain, warmth and positive biochemical markers for inflammation (CRP, WCC), requiring antibiotics, either orally or intravenously.
Timepoint [2] 307951 0
Within 30 days of operation.
Secondary outcome [3] 307952 0
Assessment of scars at donor site on postoperative week 6 using Vancouver Scar Scale.
Timepoint [3] 307952 0
At 6 weeks postop.
Secondary outcome [4] 307953 0
Patient satisfaction scored on a scale of 1 to 5, 1 being very dissatisfied to 5 being very satisfied.
Timepoint [4] 307953 0
At 6 weeks postop.

Eligibility
Key inclusion criteria
Participants will be adults (aged 18 years or older) undergoing split skin grafting at Dandenong Hospital. To be included, patients will have a traumatic wound or large skin neoplasms in lower limbs requiring excision leaving a skin defect of at least 10cm2.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient unable to provide consent due to cognitive impairment (e.g. intellectual disability, dementia, delirium, or unconscious).
2. Patients with known sensitivity or allergies to either Calcium Sodium Alginate, Kaltostat(TM) or Novel Transforming Powder, Altrazeal (TM) dressings or its components.
3. Pregnant women.

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)
60 patients who require split skin grafting of lower limbs at Dandenong Hospital for any cause, leaving DSW of more than or equal to 10cm2, will be recruited. At the time of recruitment, patients will be randomised into allocation group by using opaque sequentially numbered and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated list of random treatment allocations will be used to assign patients to treatment in a 1:1 ratio of Novel Transforming Novel Transforming Powder Dressing, Altrazeal (TM) to Calcium Sodium Alginate Dressing, Kaltostat (TM). Stata software version 12 will be used to generate random treatment allocations. Upon recruitment of participants, an assigned person independent of the study, will carry out the randomization whilst consenting for the operation itself. The operating surgeon will then be notified of the type of dressing for the donor site prior to time out.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Visual Analogue Scale (VAS) pain scores is the main efficacy end point. A sample size of 30 patients per group would have an 87% power to detect a difference of 2 points on average VAS pain scores (assuming a conservative standard deviation of 2.5 of VAS pain scores) between treatment arms with a two-sided p value of 0.05. Change in pain scores between treatment arms will be assessed using repeated measures analysis of variance. A two-sided p value of 0.05 will be considered statistically significant.
All data will be de-identified and stored in a locked cabinet or a password-protected computer at the Department of Plastic Surgery, Dandenong Hospital.
Data will be analysed using STATA 12. Univariate analysis will be conducted using student t-tests, chi-square test for equal proportion or non-parametric tests where appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/05/2014
Actual
Date of last participant enrolment
Anticipated
14/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2096 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 7781 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 288736 0
Hospital
Name [1] 288736 0
Plastic and Reconstructive Surgery Department, Monash Health
Country [1] 288736 0
Australia
Funding source category [2] 288737 0
Commercial sector/Industry
Name [2] 288737 0
Sutherland medical Pty Ltd
Country [2] 288737 0
Australia
Primary sponsor type
Hospital
Name
Plastic and Reconstructive Surgery Department, Monash Health
Address
135 David Street,
Dandenong, Victoria 3175
Country
Australia
Secondary sponsor category [1] 287433 0
None
Name [1] 287433 0
Address [1] 287433 0
Country [1] 287433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290571 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 290571 0
Level 2, I Block, Monash Medical Centre,
246 Clayton Road, Clayton, Victoria 3168
Ethics committee country [1] 290571 0
Australia
Date submitted for ethics approval [1] 290571 0
15/02/2014
Approval date [1] 290571 0
18/03/2014
Ethics approval number [1] 290571 0
13320B

Summary
Brief summary
The purpose of this study is:
1. To determine whether Novel Transforming Powder, Altrazeal (TM) dressing will consistently reduce patient’s experience of pain compared with Calcium Sodium Alginate, Kaltostat (TM).
2. To determine if there is a difference in rate of healing of the donor site between Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM).
3. To compare Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) dressings in terms of cost-effectiveness, wound infection rate and cosmetic outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46290 0
Dr Hye-Sung Park
Address 46290 0
Dandenong Hospital,
135 David Street,
Dandenong,
Victoria 3175
Country 46290 0
Australia
Phone 46290 0
+61 03 95541000
Fax 46290 0
Email 46290 0
[email protected]
Contact person for public queries
Name 46291 0
Toby Vinycomb
Address 46291 0
Dandenong Hospital,
135 David Street,
Dandenong,
Victoria 3175
Country 46291 0
Australia
Phone 46291 0
+61 433649467
Fax 46291 0
Email 46291 0
[email protected]
Contact person for scientific queries
Name 46292 0
Eldho Paul
Address 46292 0
School of Public Health and Preventive Medicine,
Monash University,
Monash Medical Centre,
246 Clayton Road, Clayton, Victoria 3168
Country 46292 0
Australia
Phone 46292 0
+61 03 95541000
Fax 46292 0
Email 46292 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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