Kero 1987.
Methods | Randomised controlled trial conducted in Finland | |
Participants | 27 people over 18 years of age with venous leg ulcers recruited
Group 1: 13 people
Group 2: 14 people Mean ± SD (range) baseline ulcer duration in months: Group 1: 12.2 ± 23.0 (1 to 72); Group 2: 54.8 ± 108.7 (1 to 360) Baseline ulcer area and infection status were not reported |
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Interventions | 1. Ulcer surface cleansed with normal saline, mechanical wound cleansing procedure carried out, dextranomer applied to ulcer surface, dry compress cover applied, and conventional compression bandage applied 2. Same as above but cadexomer iodine used | |
Outcomes | Complete healing at 8 weeks:
1. 5/13 (38%)
2. 7/14 (50%) Trial authors did not report a P value for this comparison Mean reduction in ulcer area at 8 weeks: 1. 35% 2. 81% Between‐group difference reported as non‐significant but P value not presented Secondary outcomes: Adverse events: Group 1: pain (1) Group 2: erythema (1); pain (1); stinging sensation (1) |
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Notes | Withdrawals:
Group 1:
Drug‐related S/Es (1); infection (2) Group 2: Drug‐related S/Es (1); infection (2) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "The trial was conducted under open design using random allocation to treatment with either cadexomer iodine or dextranomer" "Each patient was allocated to the treatment by using a sealed enclosure envelope containing the treatment code of the individual patient" Information taken from secondary publication (Tarvainen 1988) |
Allocation concealment (selection bias) | Unclear risk | "The trial was conducted under open design using random allocation to treatment with either cadexomer iodine or dextranomer" "Each patient was allocated to the treatment by using a sealed enclosure envelope containing the treatment code of the individual patient" Information taken from secondary publication (Tarvainen 1988) |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | "The trial was conducted under open design..." Information taken from secondary publication (Tarvainen 1988) |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | "The trial was conducted under open design..." Information taken from secondary publication (Tarvainen 1988) |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | "Two patients (one in each group) withdrew because of drug related side effects" |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | Dropout rate less than 20% |
Incomplete outcome data (attrition bias) ITT analysis | Unclear risk | "Two patients, one in each group were excluded from the evaluation of ulcer size because of infection that made cessation of therapy necessary. Two more patients, one in each group, were also excluded because of adverse reactions" |
Baseline factors comparable | High risk | Ulcer duration appeared longer in the group receiving cadexomer iodine. No information about baseline ulcer area or wound infection status |