The Topical Trial: topical sevoflurane applied to chronic non-healing ulcer wounds for up to 30 days

Phase 4

Recruiting

• Conditions: Chronic painful non-healing ulcers; Skin - Other skin conditions; Anaesthesiology - Pain management

• Registration Number: ACTRN12621001093875
• Lead Sponsor: Anaesthetic Research Department, Waikato Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-18
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in maximum pain score during dressing changes, measured by VAS, in comparison with baseline values[ At day 30 or when wound care treatment is completed- which ever comes first]

Secondary Outcome Measures

Name	Time	Method
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[ At day 30 or when wound care treatment is completed- which ever comes first]