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Trial registered on ANZCTR


Registration number
ACTRN12612000702819
Ethics application status
Approved
Date submitted
24/06/2012
Date registered
2/07/2012
Date last updated
25/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The comparison of the disposable Negative Pressure Wound Therapy Device (NPWT) to current standard dressings on medium sized Split Skin Grafts (SSG)
Scientific title
A randomised control trial pilot study for comparison of the single use Negative Pressure Wound Therapy Device (NPWT) to current standard dressings on medium sized Split Skin Grafts (SSG) for emergency and elective surgery cases to assess healing time/quality and of treatment costs
Secondary ID [1] 280728 0
Nil
Universal Trial Number (UTN)
U1111-1132-0768
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Split Skin Graft 286775 0
Condition category
Condition code
Surgery 287082 287082 0 0
Surgical techniques
Skin 287124 287124 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of Single Use, negative pressure wound dressing to medium size (between 50mmx50mm to 100mmx150mm in dimension) split skin graft. Dressing size will be directed by the size of the skin graft required. The dressing will be applied by the treating clinician at time of operation to apply the skin graft, and will take approximately 5-10 minutes to cut to size and apply. It is to remain in place for total duration of 5-7 days (selected on a case by case basis according to patient's needs and scheduled follow-up) and patient can be discharged from hospital from day after surgery.
Intervention code [1] 285152 0
Treatment: Devices
Intervention code [2] 285186 0
Treatment: Other
Comparator / control treatment
Application of standard protocol of barrier wound dressing to medium size (between 50mmx50mm to 100mmx150mm in dimension) split skin graft. The current standard protocol of barrier wound dressing on SSG consisting of a combination of jelonet/gauze/hypafix and/or crepe bandaging. This will be selected according to position of the graft, with grafts to limbs more likely to require crepe bandaging for re-information. Patient is to remain as in-patient under direct observation until day 5-7 after initial surgical intervention
Control group
Active

Outcomes
Primary outcome [1] 287407 0
Equivalent/improved wound healing rates in direct observation measured as total graft take. Patients will have a photograph of their wound pre-graft and at review in outpatients. These will be subjectively assessed by an independent and blinded surgical consultant who will grade the level of take. Further to this, an objective measure of the total graft size and take will be assessed with the Visitrak system at time of outpatient review.
Timepoint [1] 287407 0
Between 5-14 days after initial surgical procedure of split skin grafting.
Secondary outcome [1] 298079 0
Cost benefit analysis between different dressing types, dependent on average cost of dressings and total length of inpatient stay.
Timepoint [1] 298079 0
At the end of the study
Secondary outcome [2] 298080 0
Patient satisfaction with dressing type, dependent on comfort, impact on activities of daily living and ease of care. This will be directed by a likert patient questionnaire.
Timepoint [2] 298080 0
At initial outpatient review, between 5-14 days after initial surgical procedure.
Secondary outcome [3] 298081 0
Complication rates of two dressings, including but not limited to surgical site infection and bleeding. This will be clinically assessed at time of outpatient review.
Timepoint [3] 298081 0
At initial outpatient review, between 5-14 days after initial surgical procedure.

Eligibility
Key inclusion criteria
Patients requiring medium sized split skin grafts between dimensions of 50x50mm to 100x150mm for primary wound closure, recruited as either emergency or elective surgical cases through the Royal Adelaide Hosptial Plastic and Reconstructive Surgery department, fit and able to give informed consent for surgery
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor compliance/behavioural issues, Patients who live alone in the community, patients who may immeadiately require in the post-operative period MRI/Hyperbaric Chamber and/or Defibrillation, unsuitable graft bed for split skin graft take including presence of nectrotic eschar/exposed vessels/infected wound bed/deep tissue malignancy, uncompensated chronic disease that would affect patient suitability for surgery, patient currently on antiplatelet/anticoagulant medications

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)
Eligible patients will be identified by doctors working in the Royal Adelaide Hospital Department of Plastic and Reconstructive Surgery. This may include patients identified either through elective admissions with initial contact through the Royal Adelaide Hospital Plastic and Reconstructive Surgery Outpatient Department OR emergency admissions assessed by Royal Adelaide Hospital Plastic and Reconstructive Surgery Registrar/Consultant in the Emergency Department. Patients will be allocated by a computer based random number generator and assigned to an intervention concealed in a numbered opaque envelope to be opened by the treating surgeon when the patient is first brought into the operating theater for their initial operation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be allocated into the two treatment arms of the trial by using a randomisation table created by computer
software (computerised sequence generation). Randomisation will be conducted by a junior member of surgical team not directly involved in the study.
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
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 285513 0
Hospital
Name [1] 285513 0
Department of Plastic and Reconstructive Surgery
Address [1] 285513 0
Department of Plastic and Reconstructive Surgery
Level 5 North Wing Link
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country [1] 285513 0
Australia
Primary sponsor type
Individual
Name
Dr Anthony Farfus
Address
Department of Plastic and Reconstructive Surgery
Level 5 North Wing Link
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 284352 0
Individual
Name [1] 284352 0
Mr Yugesh Caplash
Address [1] 284352 0
Department of Plastic and Reconstructive Surgery
Level 5 North Wing Link
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country [1] 284352 0
Australia
Secondary sponsor category [2] 284353 0
Individual
Name [2] 284353 0
Mr Vincent Panicker
Address [2] 284353 0
Clinical Service Coordinator,
Department of Plastic and Reconstructive Surgery
Ward S5, North Wing,
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country [2] 284353 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287527 0
Royal Adelaide Hospital
Ethics committee address [1] 287527 0
Research Ethics Committee
Level 3 HANSON INSTITUTE,
Royal Adelaide Hospital
North Terrace, Adelaide South Australia 5000
Ethics committee country [1] 287527 0
Australia
Date submitted for ethics approval [1] 287527 0
Approval date [1] 287527 0
13/06/2012
Ethics approval number [1] 287527 0

Summary
Brief summary
Negative Pressure Wound therapy (NPWT) has been used in surgery for over 15 years for a whole range of wounds with good outcomes and many advantages to promote wound healing.
Recent technological advancements have led to the production of a single use NPWT device designed for small to medium size wounds with low-moderate levels of exudates.
Early uses of the dressing in literature have shown through individual case studies the potential use of Pico dressing for skin grafts leading to an earlier discharge date. However, there have been no broader studies of the use of Pico dressing in this specific treatment group. The Pico dressing is a type of single use negative pressure wound therapy produced by company Smith and Nephew.
The study has been designed as a randomised control prospective trial. The main hypothesis to be tested is that the use of a single use negative pressure wound therapy with early discharge from hospital will have equal efficacy in wound healing to the current protocol of wound therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34358 0
Dr Anthony Farfus
Address 34358 0
Royal Adelaide Hospital, Department of Surgery
Country 34358 0
Australia
Phone 34358 0
82224000
Fax 34358 0
Email 34358 0
anthony.farfus@sa.gov.au
Contact person for public queries
Name 17605 0
Dr Dr Anthony Farfus
Address 17605 0
Department of Plastic and Reconstructive Surgery
Level 5 North Wing Link,
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country 17605 0
Australia
Phone 17605 0
+610882224000
Fax 17605 0
Email 17605 0
Anthony.Farfus@health.sa.gov.au
Contact person for scientific queries
Name 8533 0
Dr Dr Anthony Farfus
Address 8533 0
Department of Plastic and Reconstructive Surgery
Level 5 North Wing Link,
Royal Adelaide Hospital
North Terrace Adelaide SA 5000
Country 8533 0
Australia
Phone 8533 0
+610882224000
Fax 8533 0
Email 8533 0
Anthony.Farfus@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results