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

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
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.
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
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
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