Background
Study (year) | N of cases | N of IR FAL (%) |
---|---|---|
Raahave (1967) [4] | 269 | 109 (41) |
Richards (1992) [5] | 88 | 25 (28) |
Sanderson (1992) [6] | 188 | 92 (49) |
Minkowitz (2007) [7] | 60 | 42 (70) |
Vos (2012) [2] | 284 | 89 (31) |
Backes (2015) [8] | 512 | 404 (79) |
Study (year) | N of cases | N of IR in FAL | N of POWI in FAL (%) |
---|---|---|---|
Raahave (1967) [4] | 269 | 109 | 4 (3.7) |
Richards (1992) [5] | 88 | 25 | 0 (0) |
Sanderson (1992) [6] | 188 | 92 | 12 (13) |
Minkowitz (2007) [7] | 60 | 42 | 0 (0) |
Schepers (2011) [9] | 76 | 76 | 7 (9.2) |
Backes (2013) [10] | 228 | 69 | 6 (9) |
Vos (2012) [2] | 284 | 89 | 9 (11) |
Backes (2015) [ [8] | 512 | 403 | 49 (12.2) |
Methods
Participants
Inclusion criteria
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Patients ≥18 years and ≤75 years of all ethnic backgrounds
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Scheduled implant removal following foot, ankle and/or lower leg surgery
Exclusion criteria
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Removal and adding osteosynthesis material during the same procedure
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Active wound infection or (plate) fistula
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Antibiotic treatment at the time of implant removal for a concomitant disease or infection
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A medical history of an allergic reaction to a cephalosporin, penicillin, or any other β-lactam antibiotic
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Known kidney disease (or known eGFR <60 ml/min/1.73 m2)
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Pregnancy and lactation
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Immunosuppressant use in organ transplantation or rheumatoid joint disease
Interventions
Randomization
Blinding
Primary Outcome
Secondary Outcomes
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Health-related quality of life as measured by the EQ-5D questionnaire. The EQ-5D-5 L is a descriptive system of health-related quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression [13].
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Patient satisfaction as measured by a ten-point Visual Analog Scale.
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Health care resources utilization (including amongst others, number of visits to the general practitioner and use of home care organizations) as measured by way of a combination of the Dutch iMTA Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ).
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Costs (economic evaluation including budget impact analysis): the economic evaluation of antibiotic prophylaxis in patients scheduled for implant removal following a foot, ankle or lower leg fracture against no prophylaxis as its best alternative will be performed as a cost-effectiveness (CEA) as well as a cost-utility (CUA) analysis. The primary economic outcome in the CEA will be the costs per patient without a POWI, which closely relates to the clinical outcome measure. The CUA outcome is the costs per quality adjusted life year (QALY), which is a suitable outcome measure for priority setting during health care policy making across interventions, patient populations, and health care settings.