A comparison of Musaceae Musa (banana skin) versus cryotherapy for the treatment of warts in patients in primary care.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2013
INTERVENTION: The intervention is raw banana skin cut to the size of the wart and placed under occlusion with a conventional medical occlusive tape for a period of 12 hours, once daily for 2 weeks. This treatment may be extended beyond two weeks or replaced with an alternative treatment (Cryotherapy or salicyclic acid cream) for up to a period of 16 weeks. The participant will be required to take a photograph the wart before application of the banana skin every night. CONDITION: Cutaneous Warts PRIMARY OUTCOME: The clearance of cutaneous warts on digital camera photographs as assessed by an independent healthcare professional (practice nurse) blind to the treatment group at each review SECONDARY OUTCOME: Economic Analysis ; ; The primary economic evaluation will be a cost‐effectiveness analysis of the trial treatments. The evaluation will be carried out from the perspective of health services, which includes both Medicare and non‐Medicare health related costs, over a time horizon of 12 weeks. The cost of resource use will be calculated for each trial participant using the data collected on the number of visits to healthcare professionals in relation to cutaneous wart treatment and cost of other wart treatments purchased by the patient. Staff costs will be calculated using standard Medicare costs . ; Topical treatments will be costed using the PBS Formulary and manufacturer's costs where required. Patient outcome will be measured as the primary outcome i.e. complete clearance of all warts at 16 weeks. The incremental mean difference in costs between the two trial arms and incremental difference in patient outcome will be calculated and we will calculate an incremental cost effectiveness ratio of cost per patient cured at 16 weeks. If cryotherapy is less costly than banana skin treatment and more effective or if cryotherapy is more costly but less effective, then one treatment clearly dominates the other and there is a clear choice about the treatment that is cost‐effective. If non‐dominance occurs we must weigh up the potential cost implications versus patient benefit to make a decision regarding cost‐effectiveness. We will do this by relating the incremental mean costs between the two trial arms to the incremental mean outcome as a ratio, the incremental cost‐effectiveness ratio (ICER). The ICER represents the additional cost per additional patient cured. Uncertainty regarding the cost‐effectiveness analysis will be assessed using cost‐effectiveness acceptability curves. ; Pain intensity (on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable), self‐reported by patients and assessed by paper based questionnaires at each follow up period every 2 weeks. Patient satisfaction with the treatment (on a scale of 5 point scale, from 'very unhappy' to 'very happy'), self‐reported by patients and assessed by paper based questionnaires Use of painkillers (number of days painkillers taken), self‐reported by patients and assessed on a Likert scale. the likert scale will assess how much pain the participant is experiencing from the treatment on a scale from 0‐10. Where 0 = no pain and 10 = worst possible pain. INCLUSION CRITERIA: People attending Ocean Key's family practice (OKFP), Clarkson; Currambine Family Practice and Murray Medical Centre in Western Australia with cutaneous warts on their feet or hands will be invited. All participants will be 8 years and older. Those below 18 years of age will be required to provide parental consent
Epistemonikos ID: 5b9e45616e18d63b74fe68bc1f6b4c909ac94b07
First added on: Aug 25, 2024