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. 2014 Jan 10;2014(1):CD003557. doi: 10.1002/14651858.CD003557.pub5

Casoni 2002.

Methods Randomised controlled trial conducted in Italy
Participants 74 participants with vascular leg ulcers (information from author: ABPI had to be at least 0.6 for patient to be included; some patients had leg ulcers of mixed arterial/venous aetiology):
 Group 1: 22 participants
 Group 2: 26 participants
 Group 3: 26 participants
Mean ± SD [range] baseline ulcer area (mm2): Group 1: 162 ± 167 [40 to 810]; Group 2: 202 ± 140 [40 to 650]; Group 3: 180 ± 117 [60 to 560]
 Median (interquartile range) baseline ulcer area (mm2—read from box plot): Group 1: 125 (90, 170); Group 2: 170 (90, 300); Group 3: 150 (125, 220)
Median (interquartile range) baseline ulcer duration (months—read from box plot): Group 1: 10.5 (6, 24); Group 2: 7 (4, 12.5); Group 3: 7 (3, 8)
Participants in all groups received systemic antibiotics as necessary before trial treatment
Interventions All participants received the following interventions 2 weeks before trial treatment: compression, local antiseptics and systemic antibiotics in cases of proven infection
Trial treatments:
 Group 1: non‐adherent, paraffin gauze (Vaseline) dressing plus compression
 Group 2: hyaluronic acid and povidone‐iodine dressing plus compression
 Group 3: hydrocolloid dressing plus compression
Trial dressings and bandages were changed weekly. Compression could be in the form of Unna's boot; multilayer bandages; or stockings plus elastic bandage (removed at night)
Outcomes At 3 months—median percentage area reduction/25th percentile (read from box plot):
 Group 1: 90%/65%
 Group 2: 100%/90%
 Group 3: 100%/80%
Notes In terms of the median percentage area reduction—no data are available on those whose ulcers enlarged during the trial, the box plot shows only those with area reduction; full interquartile ranges are not shown
No information given about withdrawals
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: Patients were "randomised in three groups"
Comment: no information about methods for generating sequence
Allocation concealment (selection bias) Unclear risk Quote: Patients were "randomised in three groups"
Comment: no mention of allocation concealment
Blinding (performance bias and detection bias) 
 Participant blinded to the intervention Unclear risk No information provided
Blinding (performance bias and detection bias) 
 Outcome assessor blinded to the intervention Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 Drop out rate described Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 Drop out rate acceptable Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 ITT analysis Unclear risk No information provided
Baseline factors comparable High risk Ulcers in Group 2 were larger than those in the other groups. Ulcer in Group 1 were of longer during than those in the other groups.