Alinovi 1986.

Methods	Randomised controlled trial conducted in Italy. Some details of sample size estimation described but unclear whether this was a priori
Participants	48 people with 56 venous leg ulcers randomly assigned: Group 1: 24 people/26 legs Group 2: 24 people/30 legs Mean ± SD baseline ulcer size, cm2: Group 1 completers (24 people/26 legs): 12.5 ± 14.4 Group 2 completers (23 people/29 legs): 14.1 ± 15.9 Mean ± SD baseline ulcer duration (months): Group 1 completers: 11.7 ± 12.6 Group 2 completers: 10.4 ± 8.9 Patients with clinically infected ulcers were excluded from the trial, but all included patients had wounds with positive bacterial cultures
Interventions	1. Bed rest, and standard treatment of merbromin 2% solution applied to ulcer surface. Betamethasone dipropionate 0.05% cream applied to rest of leg, zinc oxide and ichthammol–impregnated gauze bandage wrapped around the leg and elastic support bandage applied from toes to knee. The bandage remained in place for 20 days 2. Bed rest with standard treatment and a 10‐day course of systemic antibiotics (co‐trimoxazole, gentamicin or amikacin according to sensitivity)
Outcomes	After 20 days: Complete healing: 1. 7/26 (27%) 2. 5/30 (17%) Following the 20‐day treatment period, participants whose ulcers had not healed were treated with bandages alone (further details of bandages not provided). Eventual rates of complete healing reported as follows (assessment point not stated): 1. 20/26 (77%) 2. 21/30 (70%) Mean percentage decrease in ulcer area: 1. 57.2 ± 29.3 2. 61.6 ± 25.8 The trial authors reported the between‐group difference as not statistically significant (P value 0.56) Secondary outcomes: Bacterial eradication 1. 5/24 2. 8/24 Relationship between ulcer healing and bacteriological results in people with positive pretreatment culture, excluding healed ulcers: mean percentage decrease in ulcer area (persistent bacterial colonisation) 1. 44.8 ± 31.8 (n = 19) 2. 42.1 ± 11.9 (n = 24) Mean percentage decrease in ulcer area (eradicated bacterial colonisation) 1. 70.8 ± 19.4 (n = 19) 2. 76.6 ± 13.6 (n = 24) The trial authors reported that within‐group differences for change in ulcer area between those with persistent bacterial colonisation and eradication were statistically significant (P value 0.04 for Group 1; and P value 0.00003 for Group 2)
Notes	Bacterial culture: Staphylococcus aureus: 25.4%; Pseudomonas aeruginosa: 18.2%; B‐haemolytic strep: 14.5% Withdrawals: Group 1: 0 Group 2: intolerant of compression bandage (1) Total = 1 Unit of analysis: Some participants had multiple leg ulcers studied, but this did not appear to have been accounted for in the trialists' analyses
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Reported that "patients were.....randomly allocated." It was not reported how the sequence was generated
Allocation concealment (selection bias)	Unclear risk	"randomisation was by sealed envelope", but it was not reported whether the envelopes were opaque or sequentially numbered
Blinding (performance bias and detection bias) Participant blinded to the intervention	High risk	Not reported that those allocated to standard treatment only were given placebo
Blinding (performance bias and detection bias) Outcome assessor blinded to the intervention	Unclear risk	No details about who performed the outcome assessment or how it was performed
Incomplete outcome data (attrition bias) Drop out rate described	Low risk	One withdrawal from Group 2 because could not tolerate compression bandage
Incomplete outcome data (attrition bias) Drop out rate acceptable	Low risk	No withdrawals from Group 1; 1/24 (4%) withdrew from Group 2
Incomplete outcome data (attrition bias) ITT analysis	Low risk	Participant withdrew from intervention Group 2 because could not tolerate bandage and was "excluded from analysis". It is unlikely that exclusion of one participant from the analysis had an important impact on estimates of treatment effect
Baseline factors comparable	Unclear risk	Mean values reported for ulcer size and ulcer duration (these variables are often skewed), and so difficult to judge comparability