Kuznetsov 2009.
Methods | Randomised controlled trial conducted in Russia | |
Participants | 30 participants with venous leg ulcers recruited from surgical outpatient clinic in Moscow, Russia Group 1: 15 participants Group 2: 15 participants Numbers (%) of participants with aetiological factors for VLUs: Group 1: 11 (73) participants with varicose vein disease; 4 (27) participants post thrombophlebitis Group 2: 12 (80) participants with varicose vein disease; 3 (20) participants post thrombophlebitis Mean size of ulcer at baseline cm2 ± SD (range): Group 1: 14.8 ± 3.4 (2.5 to 50.3) Group 2: 17.4 ± 6.4 (2.2 to 99.5) Numbers (%) of participants with ulcers > 20cm2: Group 1: 5 (33) Group 2: 4 (27) Numbers (%) of participants with microbiological isolates: Group 1: Staphylococcus aureus 10 (67);Pseudomonas aeruginosa 1 (6.7);Escherichia coli 1 (6.7) Group 2: Staphylococcus aureus 9 (60);Pseudomonas aeruginosa 4 (27);Proteus species 1 (6.7) |
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Interventions | Group 1: 10% povidone‐iodine dressing (Betadine), changed daily Group 2: different dressings used according to ulcer status. If necrotic tissue present, a moist wound dressing was used (TenderWet 24). This is a wound dressing pad used in combination with Ringer's solution to continuously irrigate the wound bed for 24 hours, changed daily. Once the necrotic tissue was cleared, a foam dressing (PermaFoam) was applied and was changed every 5th day or sooner. In the case of resistant infection, the foam dressing was combined with tulle dressing containing silver (Atrauman Ag) Both groups received short‐stretch compression bandaging (Pütter‐Verband, Hartmann). No participants underwent surgery Biological and cytological assessment was undertaken at baseline and on days 7, 14 and 21 The duration of treatment was 28 days or until complete healing (whichever came first) |
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Outcomes | Primary outcomes: Numbers (%) of participants with complete healing at 21 days: Group 1: 1/15 (7) Group 2: 4/15 (27) Numbers (%) of participants with complete healing at 28 days: Group 1: 2/15 (13) Group 2: 5/15 (33) Mean change in ulcer size in cm2 at 7 days: Group 1: ‐0.35 Group 2: ‐2.09 Mean change in ulcer size in cm2 at 21 days: Group 1: ‐1.27 Group 2: ‐5.03 Mean rate of healing in cm2/d: Group 1: ‐0.06 Group 2: ‐0.24 The study authors reported that the between‐group difference was statistically significant (P value < 0.05) Secondary outcomes: Numbers (%) of participants with microbiological isolates at 21 days: Group 1: Staphylococcus aureus 7 (47), Pseudomonas aeruginosa 1 (6.7), Escherichia coli 1 (6.7) Group 2: Staphylococcus aureus 5 (33), Pseudomonas aeruginosa 3 (20), Proteus species 1 (6.7) Mean cost of complete course of treatment per group (RUB): Group 1: 6,669.84 Group 2: 14,360.15 Mean cost of treatment per participant, per day (RUB): Group 1: 16.47 Group 2: 36.82 |
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Notes | Article translated from Russian Unit of randomisation and analysis was the participant Withdrawals not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: Translation indicates that participants were randomly assigned to groups, but no details of randomisation methods were provided |
Allocation concealment (selection bias) | Unclear risk | Comment: The report contained no statement regarding the group allocation process |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | Comment: The trial was described as "open", but no details of blinding of participants were provided |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | Comment: The trial was described as "open", but no details of blinding of outcome assessors were provided |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | Comment: The trial report indicates that all randomly assigned participants completed treatment |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | Comment: The trial report indicates that all randomly assigned participants completed treatment |
Incomplete outcome data (attrition bias) ITT analysis | Low risk | Comment: The trial report indicates that all randomly assigned participants completed treatment |
Baseline factors comparable | Unclear risk | The upper end of the ulcer area range is larger in Group 2. No information was provided about baseline ulcer duration |