Introduction
Background and rationale
Methods
Study setting
Study objectives
Definitions and study outcomes
Standard prophylaxis: |
1st–3rd generation cephalosporins, co-amoxiclav, clindamycin intravenously |
Broad-spectrum antibiotic prophylaxis: |
Vancomycin 1 g together with gentamicin 5 mg/kg intravenously |
Broad-spectrum antibiotic treatment: |
4–5th generation cephalosporins, quinolones, carbapenems, vancomycin, daptomycin, linezolid, aminoglycosides, colistin, metronidazole |
Remission |
No clinical, anamnestic, radiology, or laboratory signs for infection at the test-of-cure visit |
Primary outcome |
- Remission (and inversely deep surgical site infection) at 6 weeks for surgeries without implant and 1 year for surgeries with implant |
Secondary outcomes: |
- Risk of (antibiotic-resistant) pathogens in the deep surgical site of the study patients |
- Revision surgery for non-infections reasons within 6 weeks |
- Change of antibiotic therapy for infection, based on intraoperative findings |
- Spectrum and adverse events of therapeutic antibiotic use (if any) |
- Incidence and antibiotic resistance of non-SSI infections within 6 weeks (e.g., urine) |
- Body colonization with multi-resistant bacteria at 4–-6 weeks (if any samples) |
Interventions and study conduct
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Patient’s characteristics: age, sex, immune-suppression (diabetes, renal dialysis, cirrhosis, pregnancy, medicamentous immune-suppression, untreated HIV disease, agranulocytosis, active cancer), American Society of Anesthesiologists’ (ASA) score
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Surgery and infection data: number and type of surgeries for the actual problem, agent, dose and duration of pre-surgical antibiotic therapy, local anti-infective agents, therapeutic antibiotics, pathogens and numbers of positive cultures
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Outcomes: wound problems, presence and duration of vacuum-assisted negative pressure therapy, all adverse events, all nosocomial infections during and/or after hospitalization, date and reasons for re-hospitalization and re-treatment, follow-up data, fatalities for any reason
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Visit 1—enrollment (day 1)
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End of treatment (EOT) (visit 2; end of microbiological cultures)—day 14 (± 3 days)
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Test of cure (TOC) (visit 3; surgical control after hospitalization)—day 42 (± 14 days)
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Follow-up (surgical control or by telephone) for implant surgeries—1 year (± 2 months)
Procedures at each visit
Enrolment visit (day 1)
Visit 2 (end of treatment)
Visit 3 (test of cure)
Follow-up for surgeries with implants in place
Risks for the participants
Allocation
Participant timetable
Timetable | Activity (year) | 2022 | 2023 | ||||||
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P | S | A | W | P | S | A | W | ||
P = Spring S = Summer A = Autumn W = Winter | Preparations | ||||||||
Clinical study | |||||||||
Database | |||||||||
Interim analyses | |||||||||
Final analyses | |||||||||
Writing of paper |
Monitoring and audits
Study period | Time | Monitoring activities |
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Before study | Autumn 2022 | Monitoring will be informed about study conduct concerning data sampling and safety reporting. Monitor controls if • Documents are approved • Documents are at site • Investigators are familiar with study protocol and safety reporting • Investigators know their duties and responsibilities |
Interim analysis | Autumn 2023 | All subjects: Control for existence and informed consent First trial participant and at least 10% of trial participants recruited at the time of the visit, as far as available: eligibility, primary endpoint, (serious) adverse events |
Study end | December 2024 | Control for completeness of source data |