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1. Primary
| | | |
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Resolution without relapse
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Intervention not inferior to control
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Percent cured on day 14 without relapse by day 28 [binary]
|
Absolute risk difference
|
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2. Secondary
| | | |
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Relapse by day 90
|
No difference
|
Percent with relapse [binary]
|
Chi2 ➔ Relative risk
|
|
Time to relapse
|
No difference
|
Relapse after cure [time to event]
|
Kaplan-Meier survival analysis
|
|
Objective speed of recovery
|
No difference
|
Cellulitis severity score [continuous]
|
Student’s T-test or Mann–Whitney U test
|
|
Subjective speed of recovery
|
No difference
|
Visual analogue scales of pain and swelling [continuous]
|
Student’s T-test or Mann–Whitney U test
|
|
Quality of life
|
No difference
|
SF-36 questionnaire score at day 1, 28 and 90 [continuous]
|
Student’s T-test or Mann–Whitney U test
|
|
Additional antibiotic usage
|
No difference
|
Total amount of additional antibiotic use, in DDD [continuous]
|
Student’s T-test or Mann–Whitney U test
|
|
Health care utilization
|
No difference
|
Total treatment associated costs, Health Care Utilization Questionnaire [continuous]
|
Student’s T-test or Mann–Whitney U test
|
|
3. Subgroup analyses
| | | |
|
Cellulitis severity score on a continuous scale
|
Severity score affects cure rate
| |
Regression analysis, with interaction term for severity score
|
|
Diabetes mellitus vs no diabetes mellitus
|
Diabetes affects cure rate
| |
Regression analysis, with interaction term for (no) diabetes
|
|
4. Sensitivity analyses
|
Intervention not inferior to control
|
All outcomes
| |
|
Per protocol analysis
| | |
Chi2 ➔ Relative risk
|
|
Primary outcome adjusted for covariates
| | |
Logistic regression analysis
|
