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Trial registered on ANZCTR


Registration number
ACTRN12612000885897
Ethics application status
Not yet submitted
Date submitted
17/08/2012
Date registered
20/08/2012
Date last updated
20/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial of Negative Pressure Wound Therapy (NPWT) in Hospital in the Home (HITH) to treat post-operative foot wounds
Scientific title
Does Negative Pressure Wound Therapy (NPWT) increase healing rates in post-operative foot wounds in Hospital in the Home (HITH) patients.
Secondary ID [1] 281064 0
None
Universal Trial Number (UTN)
U1111-1133-5694
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative foot wounds 287189 0
Diabetes 287206 0
Condition category
Condition code
Other 287540 287540 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative Pressure Wound Therapy (NPWT) devices will be from VAC therapy and systems range manufactured by the Kinetics Concepts Inc. (KCI)(San Antonio, TX,USA).
The duration of treatment will be determined by nurse treating patient in accordance with current practice and based on clinical assessment of healing. The foot wound will be filled with foam dressing and VAC cycle will set for continuous cycle with a target pressure of 125mmHg. Dressings will be changed every 48-72 hours but no less than 3 times per week as per manufacturers instructions for up to 8 weeks unless healing occurs sooner.
Intervention code [1] 285507 0
Treatment: Devices
Comparator / control treatment
Standard Care (SC)
Participants in the SC arm will receive a moist wound dressing as chosen by treatment nurse based on wound assessment. The dressing choices will be hydrocolloid dresing, a foam dressing or an alginate dressing. The frequency of dressing change will be determined by the nurses (standard practice). The type of dressing, reason for use, type of secondary dressing applied (if applicable) and any other treatment details will be recorded at each treatment visit ( at least once a week)
Control group
Active

Outcomes
Primary outcome [1] 287762 0
The primary endpoint will be proportion of wounds healed using clinical assessment and Visitrak wound measurement system
Timepoint [1] 287762 0
within 8 weeks compared for the two groups.
measured with clinical assesments
Secondary outcome [1] 298789 0
time to healing
Timepoint [1] 298789 0
Wound tracings will be calculated with Visitrak wound management system at baseline and weekly for 8 weeks or until healed (whichever comes first).
Secondary outcome [2] 298790 0
frequency of treatment,
Timepoint [2] 298790 0
measured with clinical assesments and nursing treatment visits weekly for 8 weeks or until healed (whichever comes first).
Secondary outcome [3] 298791 0
wound recurrence
Timepoint [3] 298791 0
1 month post healing
measured with clinical assesments and participant self report of wound recurrence
Secondary outcome [4] 298792 0
resources used/costs
Timepoint [4] 298792 0
measured weekly for 8 weeks with participant self report and medical records data
Secondary outcome [5] 298793 0
recruitment rates
Timepoint [5] 298793 0
researchers will document number of participants screened and recruited weekly for 8 weeks
Secondary outcome [6] 298830 0
Pain and health -related quality of life
Timepoint [6] 298830 0
Overall pain: Participant's global assessment of overall pain and activity-related pain will be measured with a standardized 0[no pain] -100 [maximum pain] numerical scale at each visit.
Health-related quality of life: will be meausred at Baseline and 8 weeks)

Eligibility
Key inclusion criteria
Male and female participants aged over 18 years
-Post-operative foot amputation to the trans metatarsal level of foot
greater than or equal to 5cm2 to less than or equal to 20 cm2 measured by digital planimetry
-Adequate peripheral perfusion (Ankle Brachial indices greater than 0.7mm Hg,)
-Fit Austin HITH discharge criteria
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients diagnosed with malignant foot wounds, unexplored fistula, exposed blood vessels, necrotic tissue with eschar, unstable coagulation therapy, untreated osteomyelitis and/or wound infection, malnutrition and /or low serum albumin. (NPWT guidelines)
-Patients who cannot tolerate NPWT as inpatient prior to discharge to HITH
-Patients with cognitive impairment/dementia.

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)
Settings and locations: Patients will be recruited from Austin Health inpatient and outpatient departments from Austin and Repatriation campus and will be treated in Austin HITH.
Screening: for eligibility: The attending vascular surgeon will assess participant eligibility as outlined in inclusion /exclusion criteria. Patients who meet the inclusion criteria will be provided with plain language statement and invited to participate in trial.
Randomisation: Eligible participants will be randomly assigned (1:1) to either NPWT or standard care (SC).
Allocation Concealment and Blinding: Randomised code will remain concealed from participants, clinic staff and investigators until after preliminary analyses of trial results have been completed. Blinding of clinicians and participants will not be possible. Assessment of outcomes will be performed by a bio-statistician who will not be aware of the participant’s treatment allocation.
Interventions: The NPWT group will receive V.A.C. (registered trademark) inclusive of device and dressing and canisters.
The SC group will receive dressing/s as deemed appropriate by clinicians. Dressing type will be documented in CRF.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)

Funding & Sponsors
Funding source category [1] 285830 0
Government body
Name [1] 285830 0
Department of Health Victoria
Address [1] 285830 0
50 Lonsdale Street
Melbourne 3000
VIC
Country [1] 285830 0
Australia
Primary sponsor type
Government body
Name
Department of Health Victoria
Address
50 Lonsdale Street
Melbourne 3000
VIC
Country
Australia
Secondary sponsor category [1] 284654 0
None
Name [1] 284654 0
Address [1] 284654 0
Country [1] 284654 0
Other collaborator category [1] 277022 0
Hospital
Name [1] 277022 0
Austin Health
Address [1] 277022 0
Studley park Road
Heidelberg 3084
VIC
Country [1] 277022 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287853 0
Austin Hospital ethics Committee
Ethics committee address [1] 287853 0
Henry Buck Building Austin Health
Studley Rd
Heidelberg 3084 Vic
Ethics committee country [1] 287853 0
Australia
Date submitted for ethics approval [1] 287853 0
14/08/2012
Approval date [1] 287853 0
Ethics approval number [1] 287853 0

Summary
Brief summary
Ten participants will be recruited from Austin health into this pilot randomised controlled trial to investigate if negative pressure wound therapy increases healing rates in people with post operative foot wounds in the home care setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34588 0
Address 34588 0
Country 34588 0
Phone 34588 0
Fax 34588 0
Email 34588 0
Contact person for public queries
Name 17835 0
Carolina Weller
Address 17835 0
Level 6 Alfred Centre
School of Public Health
Monash University
99 Commercial road
Melbourne
3004
Country 17835 0
Australia
Phone 17835 0
+61 3 99030623
Fax 17835 0
Email 17835 0
carolina.weller@monash.edu
Contact person for scientific queries
Name 8763 0
Carolina Weller
Address 8763 0
Level 6 Alfred Centre
School of Public Health
Monash University
99 Commercial road
Melbourne
3004
Country 8763 0
Australia
Phone 8763 0
+61 3 99030623
Fax 8763 0
Email 8763 0
carolina.weller@monash.edu

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