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Trial registered on ANZCTR


Registration number
ACTRN12621001093875p
Ethics application status
Submitted, not yet approved
Date submitted
30/07/2021
Date registered
18/08/2021
Date last updated
18/08/2021
Date data sharing statement initially provided
18/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Topical Trial: topical sevoflurane applied to chronic non-healing ulcer wounds for up to 30 days
Scientific title
A feasibility trial to evaluate the efficacy and safety of topical sevoflurane applied to chronic non-healing ulcer wounds to determine its effect on pain control and wound healing over 30 days
Secondary ID [1] 304918 0
None
Universal Trial Number (UTN)
U1111-1266-1676
Trial acronym
TTT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic painful non-healing ulcers 323057 0
Condition category
Condition code
Skin 320638 320638 0 0
Other skin conditions
Anaesthesiology 320738 320738 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Direct topical irrigation of liquid sevoflurane to chronic painful non-healing ulcer beds.
Sevoflurane comes in liquid form 100% solution
The dose will be 1ml per square centermeter of ulcer wound. A maximum of 1 application per day- or as often as a patient requires a dressing change- ie once every 2 or 3 days- up to 30 days in total or until dressing and wound care treatment is completed- whichever comes first.
Mode of delivery is via syringe- irrigated gently- prior to wound cleaning and redressing. Application of medication should take 1 min or less. The application of sevoflurane will be the responsibility of the research staff and the wound care will be the responsibility of the nursing wound care team in the hospital setting or the primary care nurses in the community.
This will involve 30 patients.
Adherance to the protocol will remain with the research staff performing the intervention.
Intervention code [1] 321312 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328454 0
Change in maximum pain score during dressing changes, measured by VAS, in comparison with baseline values
Timepoint [1] 328454 0
At day 30 or when wound care treatment is completed- which ever comes first
Secondary outcome [1] 399055 0
Once a week wound nurse subjective assessment of ulcer bed health, evidence of healing, and impact of the dressings on surrounding skin health. Composite secondary outcome
Timepoint [1] 399055 0
At day 30 or when wound care treatment is completed- which ever comes first

Eligibility
Key inclusion criteria
Inclusion Criteria:
18 Years or older
Have a chronic (>3mth) painful ulcer wound (excluding ulcers on the face and head)
Have the capacity to understand the purpose and requirements of the study
Adequate written and verbal language skills for all communication to be conducted in English.
Provide written consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
Requires surgical intervention for ulcer wound
Other topical pharmacological treatments required for the ulcer
Primary physician opposes study Intervention
Personal history or family history of malignant hyperthermia
Known allergy to Sevoflurane
Malignant ulcer
Painless ulcer

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For this treatment to be useful in clinical practise the study needs to show a dramatic benefit in treating pain for patients. If the intervention cannot show a significant benefit in a small group of 30 participants it will not have a role to play in future care of painful ulcer patients.

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 outside Australia
Country [1] 24017 0
New Zealand
State/province [1] 24017 0

Funding & Sponsors
Funding source category [1] 309297 0
Hospital
Name [1] 309297 0
Anaesthetic research department- Waikato hospital,
Address [1] 309297 0
Waikato Hospital
Waiora building Level 4
Pembroke st 3240
Hamilton
New Zealand
Country [1] 309297 0
New Zealand
Primary sponsor type
Hospital
Name
Anaesthetic Research Department, Waikato Hospital
Address
Waikato Hospital
Waiora building Level 4
Pembroke st 3240
Hamilton
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310268 0
None
Name [1] 310268 0
Address [1] 310268 0
Country [1] 310268 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309128 0
Health and Disability Ethics Committee
Ethics committee address [1] 309128 0
Ministry of Health Health and Disability Ethics Committees PO Box 5013 Wellington 6140 Street address: 133 Molesworth Street Thorndon Wellington 6011
Ethics committee country [1] 309128 0
New Zealand
Date submitted for ethics approval [1] 309128 0
16/07/2021
Approval date [1] 309128 0
Ethics approval number [1] 309128 0

Summary
Brief summary
The purpose of this study is to evaluate whether topical sevoflurane provides significant pain relief and no major side effects in managing chronic non-healing ulcers.

Chronic ulcer wounds come from a variety of causes. Often they are a sign of advanced progression of chronic diseases such as peripheral vascular disease, diabetes and renal failure. Some ulcers are not amenable to a surgical intervention. Severe pain limits noninvasive treatment options including making it difficult to adequately debride any eschar (dead tissue) or unhealthy excess granulation tissue from the ulcer at the time of dressing changes, thus increasing the chance that the ulcer will become grossly infected, and reducing the likelihood that the ulcer will heal. Ulcers can remain unhealed for many months, which may lead to systemic infection or infection of deeper tissue (muscle or bone), worsening local tissue ischaemia and enlargement of the ulcer, and transition to a malignant process. Non-malignant ulcers are typically painful, sometimes foul smelling, and often require frequent dressing changes. These features highlight why a chronic ulcer may have a profound negative impact on a patient’s quality of life
The available case reports indicate that topical sevoflurane is a promising, cost effective and safe treatment, however these are small case reports and further research is needed to show efficacy and safety across wider patient populations and to define the mechanism of action of topical sevoflurane in the setting of chronic painful ulcer management.

Currently patients with ulcers with no surgical treatment option face painful non-invasive interventions and use of strong analgesics, including opioid medications. Opioids are typically only modestly effective at relieving ulcer pain and cause a range of significant adverse side effects.

If proven, this treatment option will; make treatment of ulcers less painful for patients, reduce the negative impact of ulcers on a patients’ quality of life, decrease opioid use and the related adverse effects, and may increase the proportion of patients that achieve healing of their ulcers.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113078 0
Dr John Barnard
Address 113078 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 113078 0
New Zealand
Phone 113078 0
+6421341974
Fax 113078 0
Email 113078 0
jonathan.termaat@waikatodhb.health.nz
Contact person for public queries
Name 113079 0
Mr Jono Termaat
Address 113079 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 113079 0
New Zealand
Phone 113079 0
+64 27 4031939
Fax 113079 0
Email 113079 0
John.barnard@waikatodhb.health.nz
Contact person for scientific queries
Name 113080 0
Dr John Barnard
Address 113080 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 113080 0
New Zealand
Phone 113080 0
+64 21341974
Fax 113080 0
Email 113080 0
John.barnard@waikatodhb.health.nz

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