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. |
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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. |
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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). |
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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. |
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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. |