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Trial registered on ANZCTR


Registration number
ACTRN12619000920190
Ethics application status
Approved
Date submitted
21/05/2019
Date registered
2/07/2019
Date last updated
2/07/2019
Date data sharing statement initially provided
2/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-healing soft tissue and malignant wounds in the palliative care setting: applying Sterile Larvae Wound Therapy for wound debridement and healing.
Scientific title
Non-healing soft tissue and malignant wounds in the palliative care setting: feasibility of applying Sterile Larvae Wound Therapy for wound debridement and healing.
Secondary ID [1] 298332 0
Therapeutic Goods Administration Clinical Trial Notification: CT-2019-CTN-01546-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non-healing soft tissue 312927 0
malignant wounds 312928 0
Condition category
Condition code
Skin 311419 311419 0 0
Other skin conditions
Cancer 311483 311483 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) Sterile larvae therapy
Ward nurses will apply the wound therapy. Sterile larvae therapy (medical grade): The normal rate of application is 5-8 larvae per cm2 of wound surface area. The larvae are left on the wound site for 48-72 hours therefore wound dressings will be changed and sterile larvae therapy applied every 2-3 days. Wound assessment will be completed at each dressing change and includes assessment by treating nurses and patient reported assessment (rating pain, odour etc).

(2) Standard wound management practices which vary according to the wound.

Allocation is determined by participant consent.
Intervention code [1] 314532 0
Treatment: Other
Comparator / control treatment
Standard wound treatment: the most appropriate treatment for a each wound, based on assessment of the wound by treating nurses and doctors. This is based on current evidence around wound management.
Control group
Active

Outcomes
Primary outcome [1] 320435 0
Changes in symptom scores.

Symptom scores will be collected using a validated symptom assessment tool (ESAS).
Timepoint [1] 320435 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [1] 370671 0
To determine the incidence of non-healing soft tissue wounds and malignant wounds.

Assessed recording every new instance. Collected from medical records.
Timepoint [1] 370671 0
At time of admission to the ward (for patients admitted with malignant or non-healing wounds) or during admission (where malignant or non-healing wounds develop during admission).
Secondary outcome [2] 371585 0
Change in odour.

Collected via a wound dressing assessment chart.
Timepoint [2] 371585 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [3] 371586 0
Time to healing.

Collected via a wound dressing assessment chart.
Timepoint [3] 371586 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [4] 371587 0
Number of dressing changes

Collected via a wound dressing assessment chart.
Timepoint [4] 371587 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [5] 371588 0
Patient global impression of change.

Collected via a validated tool (PGIC)
Timepoint [5] 371588 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [6] 371589 0
Clinical global impression of change

Collected via a validated tool (CGIC)
Timepoint [6] 371589 0
Death/withdrawal or reduction in wound symptoms
Secondary outcome [7] 371719 0
Feasibility of using sterile maggot therapy in the palliative care setting determined by number of eligible patients who decline treatment with sterile maggots.
Timepoint [7] 371719 0
Completion of study.

Eligibility
Key inclusion criteria
1) with advanced disease who are inpatients of the SVPHB palliative care unit
2) have a non-healing soft tissue or malignant wound with one or more of the following elements
o necrotic tissue
o malodorous
o profuse exudate

Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) have an allergy to fly larvae, chicken eggs or soybeans.

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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
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)
QLD
Recruitment hospital [1] 13808 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) [1] 26559 0
4169 - Kangaroo Point

Funding & Sponsors
Funding source category [1] 303080 0
Hospital
Name [1] 303080 0
St Vincent's Private Hospital Brisbane
Address [1] 303080 0
411 Main Street, Kangaroo Point QLD 4169, Brisbane.
Country [1] 303080 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Private Hospital Brisbane
Address
411 Main Street, Kangaroo Point QLD 4169
Country
Australia
Secondary sponsor category [1] 302789 0
Government body
Name [1] 302789 0
NSW Health Pathology
Address [1] 302789 0
Department of Medical Entomology,
ICPMR (Level 3)
Westmead Hospital
Locked Bag 9001
WESTMEAD NSW 2145
Country [1] 302789 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303419 0
St Vincent's Health & Aged Care Human Research Ethics Committee
Ethics committee address [1] 303419 0
Holy Spirit Northside Private Hospital, 627 Rode Road, Chermside QLD 4032
Ethics committee country [1] 303419 0
Australia
Date submitted for ethics approval [1] 303419 0
Approval date [1] 303419 0
20/05/2019
Ethics approval number [1] 303419 0

Summary
Brief summary
Non-healing soft tissue and malignant wounds can be very challenging to treat in the palliative care setting. Instead of complete healing, the goals of care in this setting are to reduce symptoms such as malodour, exudate and pain, to maintain patients’ dignity and to improve quality of life. This study aims to investigate the use of sterile larvae therapy in treating non-healing soft tissue and malignant wounds in the palliative care setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93614 0
Mrs Robyn Lowe
Address 93614 0
St Vincent's Private Hospital Brisbane
Level 3, Palliative Care Inpatient Ward
411 Main Street
Kangaroo Point QLD 4169
Country 93614 0
Australia
Phone 93614 0
+61 7 3240 1111
Fax 93614 0
Email 93614 0
robyn.lowe@svha.org.au
Contact person for public queries
Name 93615 0
Mrs Amanda Fischer
Address 93615 0
St Vincent's Private Hospital Brisbane
Palliative Care Research
411 Main Street
Kangaroo Point QLD 4169
Country 93615 0
Australia
Phone 93615 0
+61 7 3240 1165
Fax 93615 0
Email 93615 0
amanda.fischer@svha.org.au
Contact person for scientific queries
Name 93616 0
Mrs Amanda Fischer
Address 93616 0
St Vincent's Private Hospital Brisbane
Palliative Care Research
411 Main Street
Kangaroo Point QLD 4169
Country 93616 0
Australia
Phone 93616 0
+61 7 3240 1165
Fax 93616 0
Email 93616 0
amanda.fischer@svha.rg.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 other documents available
Summary results
No Results