Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Recruiting
Phase 3
Interventional Study
Surgical Site Infection
Microbial Colonization
Antibiotic Resistant Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 1,100 (estimated)
- Sponsor
- Balgrist University Hospital · Other
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About This Trial
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-resist…
Trial Locations
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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 …
Contacts