ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

30/06/2024

Date data sharing statement initially provided

18/08/2021

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]

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

Condition category

Condition code

Skin

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

primary endpoint
Comparison of maximum pain score during dressing changes, measured by numerical rating scale, baseline dressing versus dressing with sevoflurane.

Timepoint [1]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Anaesthetic research department- Waikato hospital,

Address [1]

Waikato Hospital
Waiora building Level 4
Pembroke st 3240
Hamilton
New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health and Disability Ethics Committee

Ethics committee address [1]

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]

New Zealand

Date submitted for ethics approval [1]

16/07/2021

Approval date [1]

07/10/2021

Ethics approval number [1]

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

Dr John Barnard

Address

Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand

Country

New Zealand

Phone

+6421341974

Fax

N/A

john.barnard@waikatodhb.health.nz

Contact person for public queries

Name

Jono Termaat

Address

Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand

Country

New Zealand

Phone

+64274031939

Fax

N/A

jonathan.termaat@waikatodhb.health.nz

Contact person for scientific queries

Name

John Barnard

Address

Waikato Hospital
Waiora Building Level 4
Anaesthetic research department
Pembroke st 3240
Hamilton
New Zealand

Country

New Zealand

Phone

+64 21341974

Fax

N/A

John.barnard@waikatodhb.health.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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