Davidovic 2010.
| Methods | Site: Femoral to AK popliteal Study design: RCT Method of randomisation: not described Blinding: unblinded, intention to treat Exclusions post randomisation: none Losses to follow up: not specified |
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| Participants | Country: Serbia Setting: hospital No. of participants: 85 (43 ePTFE, 42 Dacron) Age (mean): 65.5 yrs Sex: 71 males, 14 females Inclusion criteria: severe claudication or critical ischaemia, "considered suitable for surgical revascularization using above‐knee prosthetic bypass graft" Exclusion criteria: previous procedures on aorto‐iliac or ipsilateral femoro‐politeal arterial segments |
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| Interventions | 8 mm FlowNit Biosel (Dacron) or 8mm FlowLine BioPore (ePTFE) bypass graft from femoral to above‐knee popliteal artery. All patients given 4 days' antibiotic prophylaxis with a second generation cephalosporine and started on acetylsalicylic acid immediately after surgery | |
| Outcomes | Primary: primary patency, early complications (mortality, bleeding and infection), early limb salvage Secondary: secondary patency, mid‐term complications (mortality, false anastomotic aneurysms and infection), mid‐term limb salvage |
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| Notes | Clear antibiotic and antiplatelet protocols | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not discussed |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Operative blinding impossible in this type of trial |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Outcome assessors and patients not obviously blinded |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Numbers at risk not presented with survival curves, secondary patency presented as worse than primary patency, which is impossible |
| Selective reporting (reporting bias) | Low risk | All outcomes presented, but numbers at risk at different time points not given so impossible to discern significance of different rates |
| Other bias | Low risk | Clear antiplatelet and antibiotic protocols |