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

Elizabeth Webb; Teresa Neeman; Jamie Gaida; Francis J Bowden; Virginia Mumford; Bernie Bissett

doi:10.1136/bmjopen-2019-029225

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

BMJ Open. 2019 Aug 15;9(8):e029225. doi: 10.1136/bmjopen-2019-029225.

Authors

Elizabeth Webb^{1

2}, Teresa Neeman³, Jamie Gaida⁴, Francis J Bowden^{5

6}, Virginia Mumford⁷, Bernie Bissett²

Affiliations

¹ Department of Physiotherapy, Calvary Public Hospital Bruce, Canberra, Australian Capital Territory, Australia.
² Discipline of Physiotherapy, Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.
³ Biological Data Science Institute, Australian National University, Canberra, Australian Capital Territory, Australia.
⁴ University of Canberra Research Institute for Sport and Exercise (UC-RISE), University of Canberra, Canberra, Australian Capital Territory, Australia.
⁵ Calvary Public Hospital Bruce, Canberra, Australian Capital Territory, Australia.
⁶ Australian National University Medical School, Australian National University, Canberra, Australian Capital Territory, Australia.
⁷ Australian Institute of Health Innovation, Macquarie University, Sydney, New South Wales, Australia.

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.

Keywords: cellulitis; compression stockings; edema; infectious diseases; lymphedema; recurrence.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Bandages*
Cellulitis / etiology*
Cellulitis / prevention & control*
Chronic Disease
Cross-Over Studies
Edema / complications*
Humans
Leg
Quality of Life
Randomized Controlled Trials as Topic
Research Design

Associated data

ANZCTR/ACTRN12617000412336