Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBalgrist University Hospital
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-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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard antibiotic prophylaxis
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov