Impact of Compression Therapy on Cellulitis (ICTOC) in adults with chronic oedema: a randomised controlled trial protocol
| Autor: | Frank J Bowden, Elizabeth Pamela Webb, James E Gaida, Virginia Mumford, Bernie Bissett, Teresa Neeman |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Adult
medicine.medical_specialty recurrence medicine.medical_treatment Population lcsh:Medicine Compression stockings law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Quality of life Randomized controlled trial law compression stockings Protocol medicine Edema Humans 030212 general & internal medicine Risk factor education Randomized Controlled Trials as Topic Leg education.field_of_study Cross-Over Studies business.industry lcsh:R Cellulitis General Medicine lymphedema medicine.disease Bandages Infectious Diseases Lymphedema Research Design Chronic Disease Cohort Emergency medicine Quality of Life business |
| Zdroj: | BMJ Open BMJ Open, Vol 9, Iss 8 (2019) |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2019-029225 |
| Popis: | IntroductionCellulitis 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 analysisA 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 disseminationEthics 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 numberACTRN12617000412336; Pre-results. The ICTOC trial is currently in progress. Participant recruitment started in May 2017 and is expected to continue until December 2019. |
| Databáze: | OpenAIRE |
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