Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery (BAPTIST)
Surgical Site Infection, Microbial Colonization, Antibiotic Resistant Infection
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Perioperative antibiotic prophylaxis, Selection, High Risk patients, Ranndomized-Controlled Trial
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Surgery under current or recent therapeutic antibiotics (antibiotic-free window <14 days and past antibiotic prescription >4 days)
- Surgery for open fractures and wounds; including 2nd and 3rd looks
- Potentially contaminated wound revision in the operating theatre
- Tumor (oncologic) surgery (if prior radiotherapy and/or bone involvement)
- Spine surgery with ASA-Score >= 3 points, sacral involvement, or re-vision surgery
- Known skin colonization with multidrug-resistant Gram-negative bacteria
Exclusion Criteria:
- Inability to understand the study procedure for linguistic or cognitive rea-sons
- Surgery without intraoperative microbiological samples
- Allergy or major intolerance to vancomycin and/or gentamicin
- Anticipated clinical follow-up of less than 6 weeks after inclusion
- Pregnant or breastfeeding women
- Known carriage of multiresistant Gram-negative bacteria in the urine or anal region
Sites / Locations
- Balgrist University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard prophylaxis arm
Innovative prophylaxis arm
The standard prophylaxis consists of one to three intravenous doses of cefuroxime 1.5 g intravenously; or cefuroxim 3g if obesity > 120 kg or a BMI > 35 kg/m2; or vancomycin 1 g or clindamycin 600 mg in case of intolerance to cephalosporins In patients alrady under current therapuetic antibiotic therapy, continuation of that therapuetic antibiotic regimen
Additional single-shot perioperative antibiotic prophylaxis with Broad-spectrum prophylaxis: vancomycin 1 g & gentamicin 5 mg/kg.