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Trial registered on ANZCTR
Registration number
ACTRN12617001291370
Ethics application status
Approved
Date submitted
29/08/2017
Date registered
6/09/2017
Date last updated
13/11/2019
Date data sharing statement initially provided
29/07/2019
Date results information initially provided
13/11/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
The efficacy of low-frequency ultrasonic debridement (LFUD) and Polyhexamethylene Biguanide (PHMB) combination therapy for adults with chronic wounds; a randomised controlled trial
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Scientific title
The efficacy of low-frequency ultrasonic debridement (LFUD) and Polyhexamethylene Biguanide (PHMB) combination therapy for adults with chronic wounds; a randomised controlled trial
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Secondary ID [1]
292728
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Nil known
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Universal Trial Number (UTN)
U1111-1201-2461
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic wounds
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Condition category
Condition code
Infection
303829
303829
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0
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Studies of infection and infectious agents
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Skin
303830
303830
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0
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each participant will receive ultrasonic debridement on their wound weekly for six weeks in a specified specialist wound clinic in the University Health Clinics. The ultrasonic procedure involves the use of a low-frequency ultrasound machine using the Sonoca 185 by Soring. This machine operates at 25kHz and is applied for 20 seconds per 1 cm2 of tissue to attain adequate bacterial kill, at 60-80% intensity, or at 40% and double the time. The use of LMX4 topical anaesthetic cream can be used prior to debridement if required to minimise discomfort.
A wound swab will be taken prior to debridement, post debridement, and, post antiseptic soak (if in the intervention group). A small piece of tissue scraping can be taken during debridement treatment if able, at week 1, 3, 6 & 12 as well as the wound swab culture.
Those in the intervention group will receive the application of antiseptic PHMB post ultrasonic debridement and in a sustained primary dressing. The antiseptic solution Prontosan contains the active ingredient PHMB and is applied as per the manufacturer guidelines for 15 mins in a soaked sterile gauze square. The dressing product that contains PHMB will be left on the wound until next dressing change. Frequency of dressing change will be determined by exudate amount. Those that require dressing changes between weekly clinic visits will require strict adherence to the regime of the Prontosan soak and continual application of the PHMB dressing product, if in the intervention group.
The debridement therapy will be performed by the Chief investigator/Clinician/Registered Nurse or the Podiatrist in the Wound Clinic who has been trained with the ultrasonic device and debridement techniques. The Registered Nurse has up to 3 years experience with this debridement method and 17 years as a Registered Nurse working with chronic wounds.
The participants will be followed weekly for a further six weeks post the six weeks of ultrasonic therapy, with either the antiseptic solution and medicated dressing product with PHMB, or if in the control group, a non-medicated dressing, for a total of 12 weeks.
To assess intervention fidelity, the participant and carer (if applicable) must first understand the importance of adhering to the particular regime and agree to attend weekly clinic visits for 12 weeks. Carers or nurses who will attend to the dressings during the week will be advised and provided with a clear written plan of the dressing trial regime and the importance of adherence. The main clinician in the clinic will ask the participant each week if the correct product was applied and check during the participant's visit. The contact details for the clinician is supplied to the participant, carer and nurses if any queries arise about the trial between clinic visits. Any violation in the protocol will involve cessation of the trial for that participant, When the participant cannot attend a weekly visit due to illness or other event, nine out of 12 visits will be considered acceptable, and will not result in cessation of the trial for that participant. All data will be included, using the intention to treat policy,
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Intervention code [1]
298970
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Treatment: Drugs
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Intervention code [2]
298971
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Treatment: Devices
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Comparator / control treatment
The control group will receive the same treatment with the weekly LFUD for six weeks, but will not receive any PHMB antiseptic solution as a soak or cleanser, and will have a non-medicated dressing, similar to the PHMB dressing, but with no antimicrobial action on their wound. i.e., the only difference is the use of the PHMB in the intervention group with the cleanser, soak, and impregnated PHMB foam dressing.
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Control group
Active
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Outcomes
Primary outcome [1]
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Bacterial counts measured via colony forming units (CFUs) from swab cultures.
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Assessment method [1]
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Timepoint [1]
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CFUs will be assessed at baseline, week 3, 6 & 12.
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Primary outcome [2]
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A change in visual signs of wound biofilm/chronic infection via a newly designed Visual Biofilm Tool.
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Assessment method [2]
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Timepoint [2]
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Clinical signs of biofilm will be assessed at baseline, week 6 and at week 12.
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Primary outcome [3]
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Wound biofilm associated with the bacterial burden measured via molecular techniques: polymicrobial numbers from DNA sequencing from swab cultures and tissue samples.
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Assessment method [3]
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Timepoint [3]
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At baseline, 6 weeks and 12 weeks.
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Secondary outcome [1]
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Percentage of wounds healed at end of the study via the PUSH Tool (Pressure Ulcer Scale for Healing).
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Assessment method [1]
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Timepoint [1]
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This will be measured at the end of the 12 week study period, and will include the use of a blind assessor who will use the PUSH Tool via photos of: the wound, exudate from old dressings and the Visitrak tracing grid,
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Secondary outcome [2]
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Rate of wound healing measured via the PUSH Tool and Visitrak tracing device.
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Assessment method [2]
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Timepoint [2]
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This will be measured at the timepoints week 1, 4, 8 & 12 and will include the use of a blind assessor who will use the PUSH Tool via photos of: the wound, exudate from old dressings and the Visitrak tracing grid,
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Secondary outcome [3]
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Pain levels will be assessed and measured via the Numerical Rating Scale (NRS).
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Assessment method [3]
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Timepoint [3]
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These pain levels will be measured at each weekly visit, prior to treatment, during and post treatment, written by the participant.
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Secondary outcome [4]
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Quality of Life (QOL) will be measured via the Wound QoL questionnaire on Health related Quality of Life in Chronic Wounds.
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Assessment method [4]
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Timepoint [4]
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QOL will be measured at baseline and at the end of the 12 week study, or upon wound healing. If the wound heals prior to the 12 week mark, the trial will end for that participant, and the QOL tool will be measured.
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Secondary outcome [5]
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Adverse reactions will be monitored via clinical observations of: increased pain by 2-3 levels using the Numerical Rating Scale (NRS); increased wound size by 20% or > in the small group, or 10% 0r > in the large group, using the Visitrak tracing device at weekly intervals; any reaction to the PHMB product such as skin rash at site of application or stinging/discomfort on application; periwound area breakdown such as skin maceration.
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Assessment method [5]
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Timepoint [5]
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Adverse reactions to be measured at weekly intervals, at each clinic visit.
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Eligibility
Key inclusion criteria
Adults 18 years plus
Chronic wound for more than 6 weeks
Wound suitable for debridement therapy
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Cognitive deficit
Malignant wound or systemic condition
spreading infection in the wound
autoimmune disease
Type 1 diabetes
sensitivity to PHMB
pregnancy
cartilage exposed in the wound
wound size < 2 cm 2 , or > 100 cm 2
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation. Strata are large and small wounds. Blocks of six will be used for randomisation to the two groups.
Small wound group are any wounds that measure below 10cm 2. The large wound group are wounds that measure above 10cm 2. Those that measure exactly 10cm2 will be included into the small group.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
A blinded outcome assessor will assess the rate of wound healing and percentage of wounds healed via photographs of the wounds and the tracing grid, at week 1, 4, 8 & 12.
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size calculation was based on estimated 20% difference in healing rate in the treatment/intervention group compared to the control group. The results of a small case study prior to this trial were combined with anecdotal evidence with the combination therapy and the results of a published trial (2012) were all examined. It was determined that in order to achieve 90% power with an alpha of 5% 23 participants will be required for each group. Allowing for drop outs a total of 50 participants is anticipated to be enrolled into the study, This number was also based on current clinic patient numbers and days of operation in the clinic.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/09/2017
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Actual
25/09/2017
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Date of last participant enrolment
Anticipated
28/09/2019
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Actual
7/08/2019
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Date of last data collection
Anticipated
28/12/2019
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Actual
21/10/2019
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
17094
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4556 - Sippy Downs
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of the Sunshine Coast
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Address [1]
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University of the Sunshine Coast
Locked Bag 4
Maroochydore DC 4558
QLD
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Country [1]
297366
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Australia
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Primary sponsor type
Individual
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Name
Marianne Wallis
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Address
School of Nursing, Midwifery and Paramedicine
University of the Sunshine Coast
Locked Bag 4
Maroochydore DC 4558
QLD
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Country
Australia
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Secondary sponsor category [1]
296343
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None
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Name [1]
296343
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Address [1]
296343
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Country [1]
296343
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298468
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UnitingCare Queensland Human Research Ethics Committee
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Ethics committee address [1]
298468
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Level 5, 192 Ann St
Brisbane QLD 4001
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Ethics committee country [1]
298468
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Australia
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Date submitted for ethics approval [1]
298468
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21/03/2017
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Approval date [1]
298468
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15/05/2017
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Ethics approval number [1]
298468
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18916
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Summary
Brief summary
The aim of this research is to determine the effectiveness of one dressing product over another on bacterial levels/counts and wound healing outcomes in a controlled clinical trial that includes the use of ultrasonic debridement therapy for adults with chronic wounds.
Chronic wounds place an enormous burden on the individual and the health care system. it is well known that individuals with non-healing wounds suffer from a reduced quality of life, experience pain, anxiety, report a financial strain, and attend frequent medical appointments. They often require antibiotics and have an increased risk of infection and further complications. There are a wide variety of dressing products available these days, all of which aim to assist the healing process. One way to assess the effectiveness of one product over another is within a clinical trial. This type of investigation can provide information to help the researcher determine how wound products perform at a cellular level.
This clinical trial will involve participants being randomly assigned to receive one of two different regimes to find out which one works best. Each participant will receive ultrasonic therapy weekly for six weeks, after that a particular dressing product will continue for a further six weeks, totaling 12 weeks or upon healing. It is hypothesised that the application of ultrasound therapy will assist with reducing the bacterial burden that is common in chronic wounds and furthermore the application of dressing products with antiseptics in combination with the ultrasound are thought to further assist with preventing bacterial burden reformation and promote wound healing. This study aims to assess this hypothesis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Marianne Wallis
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Address
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School of Nursing, Midwifery and Paramedicine
Locked Bag 4
University of the Sunshine Coast
Sippy Downs, 4556
QLD
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Country
77178
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Australia
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Phone
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+ 61 427 633 708
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Fax
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Email
77178
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[email protected]
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Contact person for public queries
Name
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Mrs Alison Vallejo
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Address
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Wound Solutions Clinic
9 Ochre Way
Sippy Downs,
QLD 4558
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Country
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Australia
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Phone
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+61 413 054 870
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Fax
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+ 61 7 54 501 882
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Marianne Wallis
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Address
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School of Nursing, Midwifery and Paramedicine
Locked Bag 4
University of the Sunshine Coast
Sippy Downs, 4556
QLD
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Country
77180
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Australia
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Phone
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+ 61 427 633 708
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Fax
77180
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual data will not be publicly available due to specifications of the human research ethics committee approvals. On reasonable request an amendment will be sponsored by the authors.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
3493
Study protocol
The study protocol is currently being submitted to...
[
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3494
Informed consent form
The Participant Information Pack has been uploaded...
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373530-(Uploaded-25-07-2019-22-26-25)-Study-related document.docx
3495
Ethical approval
[email protected]
A variation approval letter has been uploaded from...
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3496
Other
The new updated Screening Tool has been added.
373530-(Uploaded-25-07-2019-22-29-15)-Study-related document.pdf
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.
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