ICTOC
Trial question
What is the role of leg compression therapy in patients with chronic edema of the leg and recurrent cellulitis?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 84
84 patients (41 female, 43 male).
Inclusion criteria: patients with chronic edema of the leg and recurrent cellulitis.
Key exclusion criteria: younger than 18 years of age, already wearing effective compression garments ≥ 5 days per week, receiving end-of-life care, clinically unstable condition, chronic wound or a wound requiring specialist treatment, or compression therapy contraindicated.
Interventions
N=41 compression (leg compression therapy plus education on cellulitis prevention).
N=43 control (education alone).
Primary outcome
Recurrence of cellulitis
15%
40%
40.0 %
30.0 %
20.0 %
10.0 %
0.0 %
Compression
Control
Significant
decrease ▼
NNT = 4
Significant decrease in recurrence of cellulitis (15% vs. 40%; HR 0.23, 95% CI 0.09 to 0.59).
Secondary outcomes
No significant difference in hospitalization for cellulitis (7% vs. 14%; HR 0.38, 95% CI 0.09 to 1.59).
Significant decrease in change in leg volume at 12 months (-181 ml vs. 60 ml; AD -241 ml, 95% CI -365 to -117).
Significant decrease in combined quality-of-life measure for limb lymphedema (LYMQOL) at 12 months (-0.5 vs. -0.2; AD -0.3 , 95% CI -0.6 to -0.1).
Safety outcomes
No significant difference in QoL assessment.
Conclusion
In patients with chronic edema of the leg and recurrent cellulitis, compression was superior to control with respect to recurrence of cellulitis.
Reference
Elizabeth Webb, Teresa Neeman, Francis J Bowden et al. Compression Therapy to Prevent Recurrent Cellulitis of the Leg. N Engl J Med. 2020 Aug 13;383(7):630-639.
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