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. 2012 Nov 14;2012(11):CD000265. doi: 10.1002/14651858.CD000265.pub3

Szewczyk 2010.

Methods RCT performed at hospital outpatient clinic in Bydgoszcz, Poland.
Participants 46 patients recruited from a hospital‐based venous leg ulcer outpatient clinic.
Inclusion criteria: presence of venous leg ulceration confirmed by duplex scan and ABPI 0.9‐1.3; maximum ulcer surface area 15 cm2.
Exclusion criteria: non‐venous or mixed ulcer aetiology; pregnancy; presence of diabetes, lower limb atherosclerosis, arterial hypertension, cardiovascular insufficiency, rheumatoid arthritis or other autoimmune diseases.
Number of male:female patients: Group 1: 2:13; Group 2: 4:12; Group 3: 4:11.
Mean ± SD patient age in years: Group 1: 66.4 ± 9.2; Group 2: 67.5 ± 9.0; Group 3: 65.9 ± 9.2.
Mean ± SD ulcer surface area in cm2: Group 1: 4.7 ± 4.2; Group 2: 5.3 ± 3.9; Group 3: 6.0 ± 4.0.
Interventions Group 1: knee‐length, class II compression stockings fitted according to patient's limb dimensions (Maxis, PPH Real, Poland) (n = 15 patients).
Group 2: 2‐component compression bandage system (ProGuide, Smith & Nephew, UK), comprising wool layer and elastic bandage (trial report states SSB, but this does not agree with manufacturer's description of ProGuide). Bandages applied using a spiral technique and changed at least twice weekly. Bandages applied to achieve ankle sub‐bandage pressure of 40 mm Hg, and 20 mm Hg at widest part of the calf (n = 16 patients).
Group 3: 4LB (Profore, Smith & Nephew, UK), bandages applied using a spiral technique and changed at least twice weekly, to achieve ankle sub‐bandage pressure of 40 mm Hg, and 20 mm Hg at the widest part of the calf (n = 15 patients).
All patients: received hydrotherapy and mechanical wound care (unclear whether this information referred to ulcer debridement); at each clinic visit the affected limb and peri‐ulcer skin were washed, moisturised and foam or hydrocolloid dressing applied according to requirements.
Outcomes Number (%) of patients with complete healing at 12 weeks: Group 1: 8/15 (53%); Group 2: 10/16 (63%); Group 3: 9/15 (60%).
Average (presume mean) % change in ulcer surface area at 12 weeks: Group 1: ‐83.1%; Group 2: ‐98.1%; Group 3: ‐93.9% (trial authors reported P > 0.05 for between‐group differences).
Average (presumed mean) healing rate in cm2/week assessed at 12 weeks: Group 1: 0.44; Group 2: 0.55; Group 3: 0.63 (trial authors reported P > 0.05 for between‐group differences).
Notes Trial authors stated that compression bandages were applied by a qualified and trained nurse, but no further details about skill, experience or training provided.
In Groups 2 and 3, ankle sub‐bandage pressure measured using a Kikuhime manometer. Unclear whether this was assessed at every bandage change.
Ulcer surface area assessed using digital planimetry (Visitrak, Smith & Nephew, UK) at baseline and every 2 weeks thereafter.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk " . . . patients . . . were randomised into three groups".
Allocation concealment (selection bias) Unclear risk No details provided.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No mention of study withdrawals, but the report of complete healing appeared to be based on all randomised patients.
Blinded outcome assessment (healing) Unclear risk No details provided.
Baseline comparability Unclear risk Median and ranges not reported for ulcer surface area, so comparability difficult to judge. Baseline ulcer duration not reported at all.