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Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

RecruitingPhase 3Ages 18 Years - anyAllBalgrist University Hospital
NCT05502380 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases). However, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on "selection" by antibiotics used for therapy or for prophylaxis.

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📋 Eligibility rules (as published)
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
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What it tests

  • Standard antibiotic prophylaxis
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Where

1 site
Balgrist University Hospital
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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