Hansson 1998.
Methods | Randomised controlled trial conducted in Sweden | |
Participants | 153 people with non‐infected venous leg ulcers randomly assigned, only withdrawals judged to be unrelated to treatment efficacy were excluded from the analysis
Group 1: 49
Group 2: 56
Group 3: 48 Mean ± SD baseline ulcer area (cm2): Group 1: 7.1 ± 7.1; Group 2: 8.8 ± 11.9; Group 3: 10.7 ± 20.6 Data on baseline ulcer duration not reported. Patients with clinically infected ulcers excluded |
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Interventions | 1. Paraffin gauze dressing, which was changed when saturated or leaking 2. Cadexomer iodine paste, which was changed when moisture saturated, indicated by a colour change 3. Hydrocolloid dressing, which was changed when saturated or leaking All participants received a short‐stretch compression bandage (Comprilan). Treatment duration was 12 weeks. |
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Outcomes | At 12 weeks:
Ulcers completely healed:
1. 7/49
2. 8/56
5. 5/48 Mean percentage reduction in ulcer area: 1. 23.9 ± 97.4% 2. 61.6 ± 36.9% 3. 40.7 ± 56.5% Mean ulcer area reduction per week (%/wk) 1. 3 ± 14 2. 8 ± 10 3. 9 ± 8 Secondary outcomes: No statistically significant difference in the time to cease exudation between groups of the study Adverse effects: Total number of adverse events per group (group denominators unclear): 1. 26 2. 19 3. 33 Erosions around ulcer: 1. 15 2. 0 3. 10 Pain 1. 1 2. 8 3. 2 Allergy 1. 1 2. 2 3. 6 Cost of treatment in 38 people (staff time, materials, and transport) USD/ percentage ulcer area reduction 1. 12.9 2. 8.8 3. 32.5 |
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Notes | Withdrawals (NB 1 to 2 reasons per participant) Group 1: Allergy (1); increased size (8); pain (1); infection (4); adverse effects (2); not related A/Es (6); refused to continue (2) Total = 24 Group 2: Pain (6); infection (1); not related A/Es (4); poor compliance (1); protocol violation (1) Total = 13 Group 3: Allergy (5); increased size (3); infection (5); use of systemic Abx (2); not related A/Es (1); refused to continue (1) Total = 17 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "patients were randomised to receive one of three treatments"; it was not stated how the sequence was generated |
Allocation concealment (selection bias) | Unclear risk | No information about how assignment to treatment groups concealed |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | "A 12‐week, randomised, open, controlled, multicentre multinational trial...." |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | "A 12‐week, randomised, open, controlled, multicentre multinational trial...." |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | 153 participants were randomly assigned, of whom 48 withdrew |
Incomplete outcome data (attrition bias) Drop out rate acceptable | High risk | Dropout rate > 20% in all treatment groups |
Incomplete outcome data (attrition bias) ITT analysis | High risk | "28 patients (12 in cadexomer iodine, 7 in hydrocolloid, 9 in paraffin gauze group) were withdrawn from the study for reason unrelated to efficacy and were excluded from the analysis" |
Baseline factors comparable | Unclear risk | Mean values were presented for baseline ulcer area, making comparability difficult to judge. No data on baseline ulcer duration were presented |