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

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.