Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001099819
Ethics application status
Approved
Date submitted
19/03/2021
Date registered
18/08/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
18/08/2021
Date results information initially provided
13/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Topical trial: Application of an anaesthetic medication to painful ulcers to evaluate the pain relief benefit and wound healing potential
Scientific title
Topical Sevoflurane Trial
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.
Secondary ID [1] 303742 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 321193 0
Condition category
Condition code
Skin 318984 318984 0 0
Other skin conditions

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 6 patients who will receive a single dose only. This will need to show a benefit in pain relief in a single application and no major side effects.

Adherence to the protocol will remain with the research staff performing the intervention.
Intervention code [1] 320053 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326905 0
primary endpoint
Comparison of maximum pain score during dressing changes, measured by numerical rating scale, baseline dressing versus dressing with sevoflurane.




Timepoint [1] 326905 0
At each dressing change from start of intervention and up to 30 days. Dressing changes can be daily or once every 2 or 3 days. This is dependant on the assessment of wound care nurses.
The study will not increase dressing change requirements for patients.
Secondary outcome [1] 393060 0
secondary endpoint
Comparison of average pain score during the dressing changes, measured by numerical rating scale, during baseline dressing versus during dressing with sevoflurane.

Timepoint [1] 393060 0
Comparison of average pain score over the 24hr following the dressing changes, measured by numerical rating scale, after baseline dressing versus after dressing with sevoflurane.

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



Intervention assignment
Single group
Other design features
N/A
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This intervention must prove to be broadly effective in this patient population group for it to become a mainstream method of treatment of ulcers. With this in mind we expect to see dramatic improvement in a small population group, This small pilot trial aims to show the treatment is efficacious, safe and feasible before proceeding with this promising treatment into routine practise

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2021
Actual
27/11/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
11/03/2022
Date of last data collection
Anticipated
31/03/2022
Actual
18/03/2022
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 23549 0
New Zealand
State/province [1] 23549 0
Waikato

Funding & Sponsors
Funding source category [1] 308122 0
Hospital
Name [1] 308122 0
Anaesthetic research department- Waikato hospital,
Country [1] 308122 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] 308878 0
None
Name [1] 308878 0
Address [1] 308878 0
Country [1] 308878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308108 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 308108 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] 308108 0
New Zealand
Date submitted for ethics approval [1] 308108 0
16/07/2021
Approval date [1] 308108 0
07/10/2021
Ethics approval number [1] 308108 0

Summary
Brief summary
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
nil
Public notes
nil

Contacts
Principal investigator
Name 109566 0
Dr John Barnard
Address 109566 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 109566 0
New Zealand
Phone 109566 0
+6421341974
Fax 109566 0
N/A
Email 109566 0
[email protected]
Contact person for public queries
Name 109567 0
Mr Jono Termaat
Address 109567 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 109567 0
New Zealand
Phone 109567 0
+64274031939
Fax 109567 0
N/A
Email 109567 0
[email protected]
Contact person for scientific queries
Name 109568 0
Dr John Barnard
Address 109568 0
Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand
Country 109568 0
New Zealand
Phone 109568 0
+64 21341974
Fax 109568 0
N/A
Email 109568 0
[email protected]

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.