Impact of compression therapy on cellulitis (ICTOC) in adults with chronic oedema

A randomised controlled trial protocol

Elizabeth Pamela WEBB, Teresa Neeman, James Gaida, Frank Bowden, Virginia Mumford, Bernie BISSETT

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Article numbere029225
Pages (from-to)1-8
Number of pages8
JournalBMJ Open
Volume9
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

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Cellulitis
Clinical Protocols
Edema
Randomized Controlled Trials
Therapeutics
Recurrence
Lower Extremity
Quality of Life
Ethics
Ethics Committees
Survival Analysis
Random Allocation
Leg
Hospitalization
Extremities
Outcome Assessment (Health Care)

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WEBB, Elizabeth Pamela ; Neeman, Teresa ; Gaida, James ; Bowden, Frank ; Mumford, Virginia ; BISSETT, Bernie. / Impact of compression therapy on cellulitis (ICTOC) in adults with chronic oedema : A randomised controlled trial protocol. In: BMJ Open. 2019 ; Vol. 9, No. 8. pp. 1-8.
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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.",
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Impact of compression therapy on cellulitis (ICTOC) in adults with chronic oedema : A randomised controlled trial protocol. / WEBB, Elizabeth Pamela; Neeman, Teresa; Gaida, James; Bowden, Frank; Mumford, Virginia ; BISSETT, Bernie.

In: BMJ Open, Vol. 9, No. 8, e029225, 01.08.2019, p. 1-8.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Impact of compression therapy on cellulitis (ICTOC) in adults with chronic oedema

T2 - A randomised controlled trial protocol

AU - WEBB, Elizabeth Pamela

AU - Neeman, Teresa

AU - Gaida, James

AU - Bowden, Frank

AU - Mumford, Virginia

AU - BISSETT, Bernie

N1 - © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

AB - 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.

KW - cellulitis

KW - compression stockings

KW - edema

KW - infectious diseases

KW - lymphedema

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