Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000454279
Ethics application status
Approved
Date submitted
2/03/2009
Date registered
15/06/2009
Date last updated
15/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Traditional portable vacuum dressings versus simple non-mechanized negative pressure dressings in the treatment of lower limb split thickness skin grafting.
Scientific title
A study assessing graft survival in patients requiring split thickness skin grafts by comparing non-mechanised negative pressure dressings to mechanised vacuum dressing
Universal Trial Number (UTN)
Trial acronym
NEWVAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Split thickness skin grafting to lower limb 3919 0
Condition category
Condition code
Surgery 4111 4111 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
non-mechanised [belovac] dressing.
Jelonet, dry sterile foam with belovac drain, occlusive dressing are placed on the wound at the time of surgery and remain in situ for 5/6 days post-op. Negative pressure via the belovac drain is apllied for the entire duration. Dressing is then taken down by member of research team, photograph taken and reviewed by blinded team member.
Intervention code [1] 3638 0
Treatment: Devices
Comparator / control treatment
Commercial KCI vaccum dressings with commercial vaccuum pump placed on the wound at the time of surgery and remain in situ for 5/6 days post-op with continuous pressure of 125mmHg. Dressing is then taken down by member of research team, photograph taken and reviewed by blinded team member.
Control group
Active

Outcomes
Primary outcome [1] 5003 0
5/6 day graft survival
Timepoint [1] 5003 0
Operations and follow up were performed between July 2008 and January 2009
Primary outcome [2] 5004 0
day 5 graft survival as assessed by health care professionals upon removal of graft at this time.
Timepoint [2] 5004 0
5/6 days post-op is the recognised gold standard for removal of dressing and assessment of graft take
Secondary outcome [1] 8447 0
nil
Timepoint [1] 8447 0
nil

Eligibility
Key inclusion criteria
patients requiring split thickness skin grafting of lower limb
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient not requiring split thickness skin grafting of the lower limb

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
patients were allocated sequentially. The first patient presenting was placed in group A, the next in group B, the next in group A and so on until enrollment was complete
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
Completed
Date of first participant enrolment
Anticipated
31/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4588 0
Self funded/Unfunded
Name [1] 4588 0
Country [1] 4588 0
Primary sponsor type
Hospital
Name
Gold Coast Hospital
Address
108 Nerang Street Southport Queensland 4215
Country
Australia
Secondary sponsor category [1] 4633 0
None
Name [1] 4633 0
Address [1] 4633 0
Country [1] 4633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6636 0
Gold Coast Health Service District Human research ethics committee
Ethics committee address [1] 6636 0
Ethics committee country [1] 6636 0
Australia
Date submitted for ethics approval [1] 6636 0
29/09/2008
Approval date [1] 6636 0
26/11/2008
Ethics approval number [1] 6636 0
200892

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29090 0
Address 29090 0
Country 29090 0
Phone 29090 0
Fax 29090 0
Email 29090 0
Contact person for public queries
Name 12247 0
Dr Ben McArdle
Address 12247 0
Division of Surgery
108 Nerang Street Southport Queensland 4215
Country 12247 0
Australia
Phone 12247 0
+61755198211
Fax 12247 0
+61755198430
Email 12247 0
[email protected]
Contact person for scientific queries
Name 3175 0
Dr Ben McArdle
Address 3175 0
Division of Surgery
108 Nerang St Southport Queensland 4215
Country 3175 0
Australia
Phone 3175 0
+61755198211
Fax 3175 0
+61755198430
Email 3175 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.