| |
Visit 1
|
Visit 2
|
Visit 3
|
Visit 4
|
Visit 5
|
Visit 6
|
|---|
| |
Day 1
|
Day 2-3
|
Day 5-6
|
Day 14
|
Day 28
|
Day 90
|
|---|
|
Assessment
| | | | | | |
|
Informed consent
|
X
| | | | | |
|
In-/Exclusion criteria
|
X
| | | | | |
|
Baseline characteristics
|
X
| | | | | |
|
Randomization criteria
| |
X
|
X
| | | |
|
Randomization of patients eligible for randomization
| | |
X
| | | |
|
Physical examination
|
X
| |
X
|
X
|
X
| |
|
Cellulitis severity score
|
X
|
X
|
X
|
X
|
X
| |
|
VAS
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Medication adherence
| | | |
X
| | |
|
Non-study medication
|
Updated throughout study
|
|
Lab and culture results
|
Updated throughout study
|
|
Questionnaires
| | | | | | |
|
SF-36
|
X
| | | |
X
|
X
|
|
EQ-5D
|
X
| | | |
X
|
X
|
|
HCRUQ
| | |
X
| |
X
|
X
|
|
Specimen collection
| | | | | | |
|
Blood samples
|
X
|
X
|
X
|
X
|
X
| |
|
Skin biopsy*
|
X
| | | | | |
|
Skin swabs
|
X
| | |
X
| | |
- VAS = visual analog scales on pain and swelling; SF-36 = Short Form (36) questionnaire; EQ-5D = EuroQol-5D questionnaire; HCRUQ = health-care resource utilisation questionnaire. *only performed in patients admitted to the main study site.
