Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Recruiting now · Phase 3
Conditions studied: Surgical Site Infection, Microbial Colonization, Antibiotic Resistant Infection
In brief
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.
Key facts
- Study ID
- NCT05502380
- Run by
- Balgrist University Hospital
- People needed
- 1100
- Starts
- 2022-09-15
- Expected to finish
- 2025-12-12
- Last updated by the study team
- 2024-12-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Balgrist University Hospital — Zurich, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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