Actively Recruiting
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Led by Balgrist University Hospital · Updated on 2024-12-02
1100
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60; 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 second and third look surgeries
- Potentially contaminated wound revision performed in the operating room
- Tumor (oncologic) surgery with prior radiotherapy and/or bone involvement
- Spine surgery with ASA score 60; 3 points, sacral involvement, or revision surgery
- Known skin colonization with multidrug-resistant Gram-negative bacteria
You will not qualify if you...
- Unable to understand study procedures due to language or cognitive issues
- Surgery without intraoperative microbiological sampling
- Allergy or major intolerance to vancomycin and/or gentamicin
- Expected clinical follow-up less than 6 weeks after inclusion
- Pregnant or breastfeeding women
- Known carrier of multiresistant Gram-negative bacteria in urine or anal region
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Balgrist University Hospital
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
I
Ilker Uçkay, Professor
CONTACT
M
Mazda Farshad, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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