Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000618459
Ethics application status
Approved
Date submitted
22/04/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Negative Pressure Wound Therapy in the community
Scientific title
Effectiveness of Negative Pressure Wound Therapy in the Community: Wound closure of post surgical wounds post hospital discharge
Secondary ID [1] 314253 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound 337174 0
Condition category
Condition code
Skin 333592 333592 0 0
Other skin conditions
Public Health 333709 333709 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - application of a negative pressure device of -125mmHg on post acute wounds by a clinical nurse
Duration- the patient will be trialled with the product for 2 to 4 weeks with frequency of dressing changes determined by the clinical nurse.
The location of the trial will be conducted within the community in the clients home and will need to be located within the Metro South Health and Hospital catchment.
Monitoring will be conducted through reviewing patient chart.
The pressures are set for each device and the pressure cannot be titrated.
Group allocation will be determined through the choice of participants and at the discretion of the clinical nurses.
Intervention code [1] 330866 0
Treatment: Devices
Comparator / control treatment
Control group - NPWT Device at -80mmHg on post acute wounds
Control group
Active

Outcomes
Primary outcome [1] 341171 0
Wound area reduction rates
Timepoint [1] 341171 0
Baseline and commencement of the trial and at 4 weeks post intervention. Follow up will be conducted at another 4-6 weeks post trial completion via telephone.
Secondary outcome [1] 446628 0
Wound moisture balance
Timepoint [1] 446628 0
Wound moisture balance is determined at every specific wound dressing change intervention conducted by the clinical nurse .
Secondary outcome [2] 446629 0
Patient satisfaction with device
Timepoint [2] 446629 0
Baseline and at 4 weeks and 8 weeks post-trial completion
Secondary outcome [3] 446630 0
Clinician satisfaction
Timepoint [3] 446630 0
Prior to the commencement of the study, 1 week prior and a follow up clinician satisfaction 8 weeks post-trial completion

Eligibility
Key inclusion criteria
Wound referrals received from hospitals within the Metro South catchment area.
Wounds that are post surgical (ie incision and drainage of abscess, surgical dehiscence)
People who have a wound over the age of 18 years
People who reside within their own home within the community
People with a medicare card
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People < 18 years
People with chronic wounds who have a longer healing trajectory
People who live in nursing homes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2025
Actual
Date of last participant enrolment
Anticipated
28/11/2025
Actual
Date of last data collection
Anticipated
7/01/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 318776 0
Government body
Name [1] 318776 0
Metro South Hospital and Health Service
Country [1] 318776 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MolnLycke
Address
Country
Switzerland
Secondary sponsor category [1] 321214 0
None
Name [1] 321214 0
Address [1] 321214 0
Country [1] 321214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317384 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 317384 0
Ethics committee country [1] 317384 0
Australia
Date submitted for ethics approval [1] 317384 0
02/12/2024
Approval date [1] 317384 0
13/12/2024
Ethics approval number [1] 317384 0

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

Contacts
Principal investigator
Name 140882 0
Miss Carla Champion
Address 140882 0
Metro South Hospital and Health Service Community and Oral Health; 51 McKechnie Drive, EIGHT MILE PLAINS QLD 4113
Country 140882 0
Australia
Phone 140882 0
+61403319928
Fax 140882 0
Email 140882 0
[email protected]
Contact person for public queries
Name 140883 0
Carla Champion
Address 140883 0
51 McKechnie Drive, EIGHT MILE PLAINS QLD 4113, Eight Mile Plains Community Health Centre
Country 140883 0
Australia
Phone 140883 0
+610731569400
Fax 140883 0
Email 140883 0
[email protected]
Contact person for scientific queries
Name 140884 0
Carla Champion
Address 140884 0
51 McKechnie Drive, EIGHT MILE PLAINS QLD 4113, Eight Mile Plains Community Health Centre
Country 140884 0
Australia
Phone 140884 0
+610731569400
Fax 140884 0
Email 140884 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.