Sustained benefit of compression therapy for preventing recurrent leg cellulitis: extended follow-up of a randomised controlled trial.

Abstract

Recurrent cellulitis causes substantial morbidity, healthcare use, and repeated antibiotic exposure. Chronic oedema is a key modifiable risk factor for incident and recurrent cellulitis, yet preventive strategies targeting oedema remain underused. Our randomised controlled trial previously demonstrated that compression therapy reduced cellulitis recurrence, leading to early trial cessation for efficacy at interim analysis. We report extended follow-up outcomes. We conducted extended follow-up of a single-centre, open-label randomised controlled trial in an outpatient setting among Australian adults with chronic leg oedema and recurrent cellulitis. Participants were randomised 1:1 to receive cellulitis prevention education (control) or education plus compression therapy, stratified by prophylactic antibiotic use. After a pre-specified interim analysis demonstrated efficacy, recruitment ceased. Compression therapy was subsequently provided to control participants, with timing determined by participant preference and clinical availability. Follow-up continued until 18 months post-enrolment. The primary outcome was time to cellulitis recurrence. Secondary outcomes included cellulitis-related hospitalisation. Analyses were by intention-to-treat in the originally assigned groups. This study is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000412336). Between June 2017 and March 2019, 183 individuals were screened and 90 were enrolled (45 per group). Median follow-up increased from 6 to 18 months. Cellulitis occurred in nine participants (20%) in the compression group and 21 (47%) in the control group (hazard ratio 0·23, 95% CI 0·10-0·52; p = 0·0001). Hospitalisation for recurrent cellulitis occurred in four (9%) compression participants and eight (18%) controls (hazard ratio 0·25, 95% CI 0·07-0·90). Adherence to compression therapy remained high throughout follow-up, with 85% of participants reporting garment use ≥4 days per week. Compression therapy provides a durable reduction in recurrent leg cellulitis and related hospitalisation in patients with chronic oedema. As an effective non-pharmacological intervention, compression therapy should be considered a first-line preventive strategy, with important implications for patient outcomes, antibiotic stewardship, and healthcare resource use. In-kind provision of compression garments by Haddenham Healthcare.