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Trial registered on ANZCTR


Registration number
ACTRN12614001200673
Ethics application status
Approved
Date submitted
28/10/2014
Date registered
14/11/2014
Date last updated
20/11/2019
Date data sharing statement initially provided
20/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective randomized controlled study of PICO dressing for lower leg wounds requiring a split thickness skin graft
Scientific title
Prospective randomized controlled study: non-inferiority of skin graft take rate with the use of PICO dressing for lower leg wounds.
Secondary ID [1] 285553 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin graft 293372 0
Lower leg wound 293440 0
Condition category
Condition code
Surgery 293656 293656 0 0
Other surgery
Skin 293713 293713 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative-pressure wound therapy system called PICO.
PICO is a small portable device that is used to treat wounds. The PICO is carried by the patient in a back pants pocket or wherever it is the most confortable for them.
The device is left switched on for 7 consecutive days. There are no dressing changes during that period.
The PICO devive can be disconnected from the dressing for showering.
The PICO pump maintains negative pressure wound therapy at 80 mmHg (nominal) +/- 20 mmHg to the wound
surface.
Intervention code [1] 290498 0
Treatment: Devices
Comparator / control treatment
Standard treatment will the use of the following for wound dressing : Jelonet or Adaptic, gauze or foam, velband, crepe bandage and tubigrip.
Control group
Active

Outcomes
Primary outcome [1] 293468 0
Skin graft take rate will be measure using the Visitrak Digital tablet.
The convenient and portable digital tablet is easy to handle, providing a quick, convenient and accurate area measurement. When the clinician has completed the tracing, the device emits an audible beep. The immediate default result is wound area, but functions are also provided to allow calculation of percentage wound area that is necrotic, and width and length measurements.
Timepoint [1] 293468 0
28 days
Secondary outcome [1] 311110 0
Health-related Quality of life will be measured with the WoundQoL tool.
Timepoint [1] 311110 0
7 days
Secondary outcome [2] 311111 0
Lenght of hospital stay
Timepoint [2] 311111 0
at hospital discharge.

Eligibility
Key inclusion criteria
1/ Male or female more than 18 years of age
2/ Presents with a lower leg lesion or wound requiring split thickness skin graft
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has malignancy in the wound bed or margins of the wound (except in palliative care to enhance quality of life).
Has previously confirmed and untreated osteomyelitis.
Has non-enteric and unexplored fistulas.
Has necrotic tissue with eschar present.
Has exposed arteries, veins, nerves, bones, tendon or organs.
Has anastomotic sites.
Has emergency airway aspiration.
Has pleural, mediastinal or chest tube drainage.
Has surgical suction.
Has a wound that is currently clinically infected, i.e. cellulitic or malodorous discharge.
Has a wound greater than 15 x 20 cm or more than 2cm deep.
Is not able to bear weight or mobilise due to underlying fractures or other injuries or illnesses.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2015
Actual
24/02/2015
Date of last participant enrolment
Anticipated
Actual
19/09/2016
Date of last data collection
Anticipated
Actual
7/11/2017
Sample size
Target
128
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3092 0
Frankston Hospital - Frankston

Funding & Sponsors
Funding source category [1] 290157 0
Hospital
Name [1] 290157 0
Peninsula health
Country [1] 290157 0
Australia
Primary sponsor type
Hospital
Name
Peninsula Health
Address
Peninsula health
Frankston Hospital
2 Hastings Rd,
Frankston, Vic 3199
Country
Australia
Secondary sponsor category [1] 288866 0
None
Name [1] 288866 0
Address [1] 288866 0
Country [1] 288866 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291867 0
Peninsula Health HREC
Ethics committee address [1] 291867 0
Ethics committee country [1] 291867 0
Australia
Date submitted for ethics approval [1] 291867 0
03/11/2014
Approval date [1] 291867 0
17/12/2014
Ethics approval number [1] 291867 0

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

Contacts
Principal investigator
Name 52342 0
Mrs Patricia Terrill
Address 52342 0
Patricia Terrill
Peninsula health
Frankston Hospital
2 Hastings Rd,
Frankston, Vic 3199
Country 52342 0
Australia
Phone 52342 0
(+613) 9769 6056
Fax 52342 0
Email 52342 0
pjterril@bigpond.net.au
Contact person for public queries
Name 52343 0
Dr Vicky Tobin
Address 52343 0
Dr Vicky Tobin, Department of Surgery, Peninsula Health, PO box 52 Frankston Vic 3199
Country 52343 0
Australia
Phone 52343 0
(+613) 9784 8416
Fax 52343 0
Email 52343 0
vtobin@phcn.vic.gov.au
Contact person for scientific queries
Name 52344 0
Dr Vicky Tobin
Address 52344 0
Dr Vicky Tobin, Department of Surgery, Peninsula Health, PO box 52 Frankston Vic 3199
Country 52344 0
Australia
Phone 52344 0
(+613) 9784 8416
Fax 52344 0
Email 52344 0
vtobin@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
data has been de-identified and do not have ethical approval for this


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.