Dimakakos 2009.
Methods | Randomised controlled trial conducted in Greece | |
Participants | 42 participants with venous leg ulcers that were classified as exclusively infected: Group 1: 21 participants Group 2: 21 participants Initial ulcer diameter: Group 1: < 1 cm, n = 3; 1 to 2 cm, n = 4; 2 to 3 cm, n = 5; 3 to 4 cm, n = 5; > 4 cm, n = 4 Group 2: < 1 cm, n = 2; 1 to 2 cm, n = 5; 2 to 3 cm, n = 4; 3 to 4 cm, n = 7; > 4 cm, n = 3 Initial ulcer depth: Group 1: < 0.5 cm, n = 16; > 0.5 cm, n = 5 Group 2: < 0.5 cm, n = 14; > 0.5 cm, n = 7 Number of (%) participants with ulcer duration > 1 month: Group 1: 14/21 (67) Group 2: 12/21 (57) Number of participants with initial ulcer pain (assessed with VAS where 0 = no pain, < 4 = mild pain, 4 to 7 = moderate pain, > 7 = severe pain, and 10 = worst imaginable pain): Group 1: severe, n = 5; moderate, n = 8; none/mild, n = 8 Group 2: severe, n = 5; moderate, n = 11; none/mild, n = 5 Number of participants with Staphylococcus aureus identified from swab: Group 1: 4/21 Group 2: 9/21 Number of participants with Pseudomonas aeruginosa identified from swab: Group 1: 5/21 Group 2: 7/21 Escherichia coli, Staphylococcus capitis, Enterococcus species and other bacteria were also present in some participants in both groups Number of participants with >1 wound isolate: Group 1: 13/21 Group 2: 11/21 All ulcers were infected and had clinical signs of inflammation |
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Interventions | Group 1: non‐adhesive foam (Biatain) Group 2: non‐adhesive silver‐releasing foam (Contreet Ag) All participants received wound cleansing using sterile water and a 10% povidone‐iodine solution; short stretch bandage as compression therapy; twice‐weekly dressing changes; and antibiotics if wound cultures were positive Treatment duration was 9 weeks |
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Outcomes | Numbers (%) of ulcers healed at 9 weeks: Group 1: 10/21 (48) Group 2: 17/21 (81) Number of ulcers healed at 3/4/5/6/7/8/9 weeks: Group 1: 2/1/1/1/0/2/3 Group 2: 2/3/3/2/1/2/4 Secondary outcomes: Adverse events: The trial authors reported that none of the participants experienced systemic or local side effects that could be attributed to the treatments, but no further details were provided Pain: Group 1: 1/5 participants with severe pain and 3/8 participants with moderate pain were pain‐free at 4 weeks. Moderate pain persisted in 4 participants until the end of the nine weeks. 13/21 participants were pain‐free by the end of the study Group 2: 2/5 participants with severe pain and 8/11 participants with moderate pain were pain‐free at 3 weeks. 21/21 participants were pain‐free by week 8. No microbiological outcomes were reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Forty‐two patients were included in the study and were randomised into two groups" Comment: No information was reported on the method of random sequence generation |
Allocation concealment (selection bias) | Unclear risk | "Forty‐two patients were included in the study and were randomised into two groups" Comment: No information was reported on the method of allocation concealment |
Blinding (performance bias and detection bias) Participant blinded to the intervention | Unclear risk | No information reported on participant blinding |
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention | Unclear risk | No information reported on assessor blinding |
Incomplete outcome data (attrition bias) Drop out rate described | Low risk | Comment: It appears that all randomly assigned participants completed the study |
Incomplete outcome data (attrition bias) Drop out rate acceptable | Low risk | Comment: It appears that all randomly assigned participants completed the study |
Incomplete outcome data (attrition bias) ITT analysis | Low risk | Comment: It appears that all randomly assigned participants completed the study |
Baseline factors comparable | Unclear risk | Comment: Categorical data were provided for baseline ulcer diameter and depth, and groups appeared comparable. The only information regarding baseline ulcer duration was the number of participants in each group with ulcers > 1 month duration |