Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000310662
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
21/03/2023
Date last updated
21/03/2023
Date data sharing statement initially provided
21/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Effectiveness of the Avelle™ Negative Pressure Wound Therapy System on Adults with Chronic Wounds
Scientific title
A Study to Evaluate the Effectiveness of the Avelle® Negative Pressure Wound Therapy System on Adults with Chronic Wounds
Secondary ID [1] 308604 0
Convatec (Australia) Pty Limited
WC-22-442
Universal Trial Number (UTN)
Trial acronym
VAPOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes-related foot ulcer
 328491 0
venous leg ulcer 328494 0
Condition category
Condition code
Cardiovascular 325520 325520 0 0
Diseases of the vasculature and circulation including the lymphatic system
Injuries and Accidents 325521 325521 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Avelle™ Negative Pressure Wound Therapy System is the intervention used in this study. The Avelle™ Negative Pressure Wound Therapy System is approved in Australia to treat low to moderately exuding (leaking fluid) wounds that would benefit from a Negative Pressure Wound Therapy device. It is indicated to treat different types of wounds, one which is chronic wounds like ulcers. Intervention providers will be trained on the use of the Avelle™ Negative Pressure Wound Therapy System face to face and will have access to the Instructions for Use.

There will be a minimum of five study visits that will take place over a maximum of 30 days. Based upon your wound, you may be seen for unscheduled visits at any time throughout the study period. An unscheduled visit would include the same procedures as Visit 2, as listed below. It is anticipated that you will be seen for between five and nine visits over the course of the study. Each visit is anticipated to last between 45-60 minutes. The study visits will be face to face and participants will be seen individually.

If you agree to take part in this study, the following study procedures will take place:
Informed Consent- Before any study procedures are started, you will sign a form to tell us that you understand what will happen during the study, you would like to participate, and that you agree to use the study device and have your information collected.

Inclusion / Exclusion- The Investigator will ask questions and examine your wound to ensure you qualify for the study.

Demographics- Your sex, age, height, weight, body mass index calculation, and ethnicity will be collected

Medical History- You will be asked about if you have any types of medical conditions and/ or allergies.

Concomitant Medication- Detailed information about the medications you take will be collected (Medication Name, Route, Dose, Unit, Frequency, Condition medication is taken for, Start Date, Stop Date).

Wound History- The length of time you’ve had your wound and the wound type will be collected.

Wound Assessment- The longest, widest, and deepest point of your wound will be measured. The location and appearance of the wound, along with the appearance, amount, type, and odour of the liquid from the wound will be recorded.

Peri-Wound area assessment- The area at the edge and around the wound will be assessed.

Dressing Application- The dressing will be applied over the wound.

System Initiation- The Avelle® Negative Pressure Wound Therapy pump will be started.

Documentation of any additional products used- Anything that is put onto your wound will be documented.

Adjunct Therapies- Any additional treatments for your wound will be documented.

Device Malfunctions- Any issues with the device will be recorded.

Adverse Device Events- Any unexpected events from the device that cause negative effects to health or safety will be thoroughly asked about and documented.

Serious Adverse Events- Any unexpected event that leads to a serious illness or injury will be thoroughly asked about and documented.

Adherence to the intervention will be asked verbally at study visits.
The Avelle® Negative Pressure Wound Therapy System will be applied at the study visits. The study podiatrist or nurse will clean and prepare the wound according to their clinical discretion. An appropriately sized absorbent dressing will be selected by the study podiatrist or nurse and applied to the wound. The dressing will have a port, which will connect to a tube and pump. The study podiatrist or nurse will then initiate the pump, which will begin negative pressure therapy. Negative pressure therapy will be administered throughout the course of the study, except for during times of showering or having the wound examined/ dressing changed. The pump is designed to operate for 30 days, though may be discontinued earlier based upon the discretion of the study podiatrist or nurse. The intervention will be delivered by a study podiatrist or nurse. The study visits will occur at Goulburn Valley Health.
Intervention code [1] 325051 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333363 0
Change in wound size of the target wound assessed by clinician's measurement of the wound (length, width, and depth).
Timepoint [1] 333363 0
Day 7 +/- 1 day post-commencement of intervention
Day 14 +/-1 day post-commencement of intervention
Day 21 +/-1 day post-commencement of intervention
Day 28 +/-2 days post-commencement of intervention


End of Study (up to 30 days)
Primary outcome [2] 334169 0
Exudate management will be assessed by clinical observation and rating completed by the study podiatrist or nurse. Exudate management will be assessed by:
Lack of strike through of the dressing
No loss of edge seal/adherence of the dressing
Lack of leaks of the dressing
Lack of dislodgement of the dressing
Need for dressing change
Timepoint [2] 334169 0
Day 7 +/- 1 day post-commencement of intervention
Day 14 +/-1 day post-commencement of intervention
Day 21 +/-1 day post-commencement of intervention
Day 28 +/-2 days post-commencement of intervention
Secondary outcome [1] 416750 0
Safety of the Avelle™ NPWT System assessed through data capture of adverse events in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0),

Possible adverse events include:

Blister/ Breakdown
Redness, pain, swelling, or heat at the wound/ Minor infection
Skin Irritation / Rash / Mucosal irritation/ Contact Dermatitis / Hives
Allergic Reaction


Timepoint [1] 416750 0
Up to 30 days post-commencement of intervention

Eligibility
Key inclusion criteria
Greater than or equal to 18 years old at the time of consent
Able and willing to provide informed consent
Venous insufficiency as classified by CEAP Classification of C6 or C6R or Diabetes-related foot ulcer
Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks
One diabetes-related foot ulcer or venous leg ulcer that is amenable to NPWT
Reliable and available for follow-up
Low to moderate exudate
Able to tolerate negative pressure

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System, including but not limited to: silicone/acrylic adhesives, sodium carboxymethylcellulose or nylon
Necrotic wounds or wounds with eschar present
Wound is too small or too large based on wound dressing (> 1cm2 and < 100cm2)

Wound depth >2cm

Use of hydrogel dressings /petroleum gel/ creams/oil-based products

Active treatment for cancer or completed within the last 3 months

Severe malnutrition

Visible bone/tendon or exposed articular capsule

Exposed blood vessels

Clotting disorder

Malignant wounds

Systemic infection

Untreated osteomyelitis

Participants with HbA1c greater than 10 within the last 3 months

Wounds greater than 24 months old

Previous failed NPWT within last 6 weeks on the qualifying wound

Chronic Kidney Disease score of 5


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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Determination
The primary objective of this study is that the percentage of subjects with successful wound and exudate management over the 30-day maximum study period, with success as defined below, is significantly higher than the performance goal (PG) of 80%.

The following hypotheses will be used to test whether the data in the study cohort have met the PG of 80%.
H0: p = PG
HA: p > PG

Where:
PG = 80%

p = The percentage of successful subjects in the study at the end of the 30-day maximum study period. The study hypotheses will be evaluated using a one-sided exact binomial test (alpha = 0.05).

The hypothesis to be tested is that the percentage of successful subjects at the end of the 30-day maximum study period is significantly greater than the performance goal of 80%.. It is expected that all subjects will be successful; however, for purposes of this sample size calculation, the expected percent success will be 80%. Thus, the sample size required for a one-sample exact binomial test with one-sided significance level of alpha = 0.05 will be used. The sample size required for 80% power is 22 subjects with complete datasets. With an adjustment for up to 20% attrition, the sample size increases to 27 subjects. A maximum of 30 subjects will be recruited onto the study.

Successful wound and exudate management is defined as follows:
Lack of strike through
No Loss of edge seal/adherence
Lack of Leaks
Lack of Dislodgement
Need for dressing change
Reduction in wound area

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/03/2023
Actual
Date of last participant enrolment
Anticipated
16/06/2023
Actual
Date of last data collection
Anticipated
14/07/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23714 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 39150 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 312849 0
Commercial sector/Industry
Name [1] 312849 0
Convatec Limited
Country [1] 312849 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Convatec (Australia) Pty Limited
Address
Level 1, 5 Nexus Court, Nexus Corporate Park, Mulgrave, Victoria 3170
Country
Australia
Secondary sponsor category [1] 315114 0
None
Name [1] 315114 0
Address [1] 315114 0
Country [1] 315114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312126 0
Goulburn Valley Health Human Research Ethics Committee
Ethics committee address [1] 312126 0
Goulburn Valley Health
Graham Street
Shepparton, 3630
Ethics committee country [1] 312126 0
Australia
Date submitted for ethics approval [1] 312126 0
Approval date [1] 312126 0
21/11/2022
Ethics approval number [1] 312126 0
GVH 32/22

Summary
Brief summary
The primary objective of the study is to demonstrate of whether Avelle® Negative Pressure Wound Therapy helps better management of chronic wound and exudate when used in accordance with the Instructions for Use. Exudate is the fluid that leaks out of a wound. The secondary objective is to measure ongoing safety of the Avelle® Negative Pressure Wound Therapy system.

Medications, drugs and devices have to be approved for use by the Australian Federal Government. The Avelle® Negative Pressure Wound Therapy System is approved in Australia to treat low to moderately exuding (leaking fluid) wounds that would benefit from a Negative Pressure Wound Therapy device. It is indicated to treat different types of wounds, one which is chronic wounds like ulcers. This study will gather information about the device’s ability to manage wound fluid and progress made in the healing of the wound.
The hypothesis is that the Avelle™ Negative Pressure Wound Therapy system will help the wound close and manage the fluid that leaks from the wound. The hypothesis is that the Avelle™ Negative Pressure Wound Therapy system will help the wound close and manage the fluid that leaks from the wound.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123570 0
Dr Emma Macdonald
Address 123570 0
Goulburn Valley Health,
2-48 Graham St
Shepparton,
Victoria,
3630
Country 123570 0
Australia
Phone 123570 0
+610418451733
Fax 123570 0
Email 123570 0
Emma.Macdonald@gvhealth.org.au
Contact person for public queries
Name 123571 0
Dr Emma Macdonald
Address 123571 0
Goulburn Valley Health,
2-48 Graham St
Shepparton,
Victoria,
3630
Country 123571 0
Australia
Phone 123571 0
+610418451733
Fax 123571 0
Email 123571 0
Emma.Macdonald@gvhealth.org.au
Contact person for scientific queries
Name 123572 0
Dr Emma Macdonald
Address 123572 0
Goulburn Valley Health,
2-48 Graham St
Shepparton,
Victoria,
3630
Country 123572 0
Australia
Phone 123572 0
+610418451733
Fax 123572 0
Email 123572 0
Emma.Macdonald@gvhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.