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

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
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
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
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