PICOS statement
Population | Adults (aged ≥18 years) with an infected arterial pseudoaneurysm secondary to groin injecting drug use (this may involve the common femoral, superficial femoral, profunda femoris, external iliac or common iliac arteries) |
Intervention | Arterial reconstruction by way of repair (suture or patch repair), bypass operation (if ligation performed) or endovascular stent-graft placement±debridement and undertaken immediately (at the index surgical intervention) or during the acute admission episode |
Comparison | Ligation of the infected arterial pseudoaneurysm±debridement alone at index surgical intervention |
Outcomes | Primary outcome: major lower limb amputation Secondary outcomes: reintervention rate; rebleeding rate; development of chronic limb-threatening ischaemia; 30-day mortality and claudication |
Study design | Randomised controlled trials, prospective and retrospective observational cohort studies and case series (four or more patients) |