None listed
Conditions
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.
Interventions
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.
Sponsors
Anaesthetic Research Department, Waikato Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed