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
KW - recurrence
UR - http://www.scopus.com/inward/record.url?scp=85070807022&partnerID=8YFLogxK
UR - http://www.mendeley.com/research/impact-compression-therapy-cellulitis-ictoc-adults-chronic-oedema-randomised-controlled-trial-protoc
U2 - 10.1136/bmjopen-2019-029225
DO - 10.1136/bmjopen-2019-029225
M3 - Article
C2 - 31420389
SN - 2044-6055
VL - 9
SP - 1
EP - 8
JO - BMJ Open
JF - BMJ Open
IS - 8
M1 - e029225
ER -
