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Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol.

ABSTRACT: INTRODUCTION:Cellulitis represents a significant burden to patients' quality of life (QOL) and cost to the healthcare system, especially due to its recurrent nature. Chronic oedema is a strong risk factor for both an initial episode of cellulitis and cellulitis recurrence. Expert consensus advises compression therapy to prevent cellulitis recurrence in individuals with chronic oedema, however, there is little supporting evidence. This research aims to determine if the management of chronic oedema using compression therapy effectively delays the recurrence of lower limb cellulitis. METHODS AND ANALYSIS:A randomised controlled trial with cross-over will be used to assess the impact of compression therapy on clinical outcomes (time to next episode of cellulitis, rate of cellulitis-related hospital presentations, QOL and leg volume). Using concealed allocation, 162 participants will be randomised into the intervention (compression) or control (no compression) group. Randomisation will be stratified by prophylactic antibiotic use. Participants will be followed up at 6 monthly intervals for up to 3 years or until 45 episodes of cellulitis occur across the cohort. Following an episode of recurrent cellulitis, control group participants will cross-over to the intervention group. Survival analysis will be undertaken to assess the primary outcome measure of time to cellulitis recurrence. The hypotheses are that compression therapy to control lower limb chronic oedema will delay recurrent lower limb cellulitis, reduce the rate of associated hospitalisations, minimise affected limb volume and improve the QOL of this population. ETHICS AND DISSEMINATION:Ethics approval has been obtained from the ethics committees of all relevant institutions. Results will be disseminated through relevant peer-reviewed journal articles and conference presentations. TRIAL REGISTRATION NUMBER:ACTRN12617000412336; Pre-results. The ICTOC trial is currently in progress. Participant recruitment started in May 2017 and is expected to continue until December 2019.

SUBMITTER: Webb E

PROVIDER: S-EPMC6701661 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol.

Webb Elizabeth E Neeman Teresa T Gaida Jamie J Bowden Francis J FJ Mumford Virginia V Bissett Bernie B

BMJ open 20190815 8

<h4>Introduction</h4>Cellulitis represents a significant burden to patients' quality of life (QOL) and cost to the healthcare system, especially due to its recurrent nature. Chronic oedema is a strong risk factor for both an initial episode of cellulitis and cellulitis recurrence. Expert consensus advises compression therapy to prevent cellulitis recurrence in individuals with chronic oedema, however, there is little supporting evidence. This research aims to determine if the management of chron ...[more]

PMID: 31420389

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Project description:INTRODUCTION:Children needing intravenous antibiotics for cellulitis are usually admitted to hospital, whereas adults commonly receive intravenous treatment at home. This is a randomised controlled trial (RCT) of intravenous antibiotic treatment of cellulitis in children comparing administration of ceftriaxone at home with standard care of flucloxacillin in hospital. The study aims to compare (1) the rate of treatment failure at home versus hospital (2) the safety of treatment at home versus hospital; and (3) the effect of exposure to short course ceftriaxone versus flucloxacillin on nasal and gut micro-organism resistance patterns and the clinical implications. METHODS AND ANALYSIS: INCLUSION CRITERIA:children aged 6 months to <18 years with uncomplicated moderate/severe cellulitis, requiring intravenous antibiotics. EXCLUSIONS:complicated cellulitis (eg, orbital, foreign body) and immunosuppressed or toxic patients. The study is a single-centre, open-label, non-inferiority RCT. It is set in the emergency department (ED) at the Royal Children's Hospital (RCH) in Melbourne, Australia and the Hospital-in-the-Home (HITH) programme; a home-care programme, which provides outreach from RCH. Recruitment will occur in ED from January 2015 to December 2016. Participants will be randomised to either treatment in hospital, or transfer home under the HITH programme. The calculated sample size is 188 patients (94 per group) and data will be analysed by intention-to-treat. PRIMARY OUTCOME:treatment failure defined as a change in treatment due to lack of clinical improvement according to the treating physician or adverse events, within 48 h SECONDARY OUTCOMES:readmission to hospital, representation, adverse events, length of stay, microbiological results, development of resistance, cost-effectiveness, patient/parent satisfaction. This study has started recruitment. ETHICS AND DISSEMINATION:This study has been approved by the Human Research Ethics Committee of the RCH Melbourne (34254C) and registered with the ClinicalTrials.gov registry (NCT02334124). We aim to disseminate the findings through international peer-reviewed journals and conferences. CLINICAL TRIAL:Pre-results.

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Dataset Information

Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol.

Publications

Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol.

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