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. |