Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000995279
Ethics application status
Approved
Date submitted
13/11/2009
Date registered
17/11/2009
Date last updated
4/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Wound Outcomes in Negative Pressure Dressings (WOUNDS) - Suction dressings and mobility compared to conventional dressings and bed rest for healing of split skin grafts of the lower leg.
Scientific title
A prospective randomised control trial of lower leg skin grafts with negative pressure suction dressing and early mobilisation versus conventional dressings for rate of graft success.
Secondary ID [1] 1136 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical skin grafts 252199 0
Condition category
Condition code
Surgery 252394 252394 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
mobile suction dressing (Vacuum Assisted Closure or VAC device), early mobilisation: The negative pressure dressing will consist of a mobile VAC system, comprising of a dressing and suction tubing on a piece of foam secured on the graft with gelonet and staples. The VAC dressing group will be discharged on the same day and will be only mobilising to bathroom, kitchen and their bedroom. The VAC dressing is kept on for 5 to 7 days and is not disturbed over this period (so it is not reapplied).
Intervention code [1] 241551 0
Treatment: Devices
Comparator / control treatment
Conventional dressings comprising of crepe, standard wound dressing material and softban and bed rest for 5 days before dressings are taken down and wound is assessed for graft take.
Control group
Active

Outcomes
Primary outcome [1] 253268 0
Graft success at day 5-7 when dressings removed as measured by a standardised wound photograph: Each wound is to be photographed with a scale ruler in place to aid calculation of wound area then mapped with GIMP image processing software to assess percentage of take (defined as the area that is attached to the underlying tissue and viable).
Timepoint [1] 253268 0
5-7 days from initial skin graft and dressing application. The wound is only assessed once during this period.
Secondary outcome [1] 262267 0
Graft success at follow up clinic in 6 weeks from operation as measured by a standardised wound photograph: Each wound is to be photographed with a scale ruler in place to aid calculation of wound area then mapped with GIMP image processing software to assess percentage of take (defined as the area that is attached to the underlying tissue and viable).
Timepoint [1] 262267 0
6 weeks from initial skin graft and dressing application.

Eligibility
Key inclusion criteria
1.Patients with lower leg wounds requiring split skin grafting for primary closure e.g. post planned skin lesion removal or trauma, referred to the two specialist surgeons (Mr H. Hammodat, Mr R. Martin)
2.Willing and able (i.e. not transferred to another hospital for whatever reason) to remain in North Shore Hospital after skin grafting for 5-7 days for graft check and/or return to North Shore Hospital in 5-7 days for graft check and dressing change
3.Fit for surgery and able to give consent for the study
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Surgical contraindications to grafting / surgery e.g
a) poor vascular supply ± venous / arterial insufficiency requiring vascular surgical intervention before grafting can be attempted
b)systemic infection – septicaemia
2.Immobility
3.Poor vascular supply to leg: either absent foot pulses OR ankle/brachial blood pressure index < 0.8 OR requires referral to vascular services before grafting
4.Enrolled in another clinical trial.
5.Lack of home support or ability to manage daily activities independently with wound dressing and drain at home.
6.Patients with chronic leg wounds / venous ulcers requiring grafting

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 flagged by the surgical doctors of the Hammodat or Martin General Surgery team at the time of outpatient clinic appointment for consideration of surgery for their leg lesion.

Participants will be randomised into two groups by simple random allocation on computer by the researcher not directly involved in the care of the participants in the trial. Allocation will be in an opaque sealed envelope, opened by the booking clerk (independent of the study researchers) at the time of booking the theatre list (to enable appropriate equipment and nursing allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into two groups by simple random allocation by computer, performed by a blinded member of the research team.
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
17/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2332 0
New Zealand
State/province [1] 2332 0

Funding & Sponsors
Funding source category [1] 244016 0
Self funded/Unfunded
Name [1] 244016 0
Country [1] 244016 0
New Zealand
Primary sponsor type
Individual
Name
Mr Richard Martin
Address
Surgical Unit
Level 8
North Shore Hospital
124 Shakespeare Road Westlake 0622
Takapuna
North Shore City
Country
New Zealand
Secondary sponsor category [1] 251367 0
None
Name [1] 251367 0
Address [1] 251367 0
Country [1] 251367 0
Other collaborator category [1] 958 0
Individual
Name [1] 958 0
Mr Hisham Hammodat
Address [1] 958 0
Surgical Unit
Level 8
North Shore Hospital
124 Shakespeare Road Westlake 0622
Takapuna
North Shore City
Country [1] 958 0
New Zealand
Other collaborator category [2] 959 0
Individual
Name [2] 959 0
Dr Lydia Chan
Address [2] 959 0
9A Moore St
Hillcrest 0627
North Shore City
Country [2] 959 0
New Zealand
Other collaborator category [3] 252175 0
Individual
Name [3] 252175 0
Dr Elizabeth de Lautour
Address [3] 252175 0
4 Ballin Street
Ellerslie 1051
Auckland
Country [3] 252175 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258123 0
Northern X ethics committee
Ethics committee address [1] 258123 0
Private Bag 92-522
Wellesley St 1141
Auckland
Ethics committee country [1] 258123 0
New Zealand
Date submitted for ethics approval [1] 258123 0
06/11/2009
Approval date [1] 258123 0
01/04/2010
Ethics approval number [1] 258123 0
Ethics study approval no. NTX/09/12/114

Summary
Brief summary
We intend to perform a prospective, randomised control trial on whether negative pressure suction dressings and early ambulation are comparable to or improve split skin graft take over conventional bolster dressings for lower leg wounds.
The lower leg is a common site for skin grafts, however healing of the skin of the lower leg can be slow leading to graft failure. Traditionally, a bolster dressing (a padded dressing over the graft) and bed rest for at least five days are recommended. Negative pressure dressings (of which the Vacuum Assisted Closure (VAC) system is commonly used internationally and in New Zealand) have been used to assist complex wound healing and graft take. The system generates a negative pressure environment which is shown to improve various factors leading to wound healing. However there is a lack of proof for whether such suction dressings improve healing more than the conventional dressings and bed rest techniques for skin grafts.
Our study is designed to determine if negative pressure suction dressings and early ambulation are comparable to or improve split skin graft take over conventional bolster dressings and bed-rest for lower leg skin graft wounds.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30510 0
Address 30510 0
Country 30510 0
Phone 30510 0
Fax 30510 0
Email 30510 0
Contact person for public queries
Name 13757 0
Mr Richard Martin
Address 13757 0
Surgical Unit
Level 8
North Shore Hospital
124 Shakespeare Road Westlake 0622
Takapuna
North Shore City
Country 13757 0
New Zealand
Phone 13757 0
(64 09) 4868920 ext 2459
Fax 13757 0
Email 13757 0
richard.martin@waitematadhb.govt.nz
Contact person for scientific queries
Name 4685 0
Dr Elizabeth de Lautour
Address 4685 0
4 Ballin Street
Ellerslie 1051
Auckland
Country 4685 0
New Zealand
Phone 4685 0
via Waitemata DHB operator switchboard
Fax 4685 0
Email 4685 0
edelautour@gmail.com

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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