Prevention of surgical site infections in orthopaedic surgery and bone trauma: state-of-the-art update.
I Uçkay, P Hoffmeyer, D Lew...
https://pubmed.ncbi.nlm.nih.gov/23414705Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05502380
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery - Prospective-Randomized, Microbiologist-Blinded, Superiority Trials
Led by Balgrist University Hospital · Updated on 2024-12-02
1100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of broad-spectrum antibiotic prophylaxis in specific orthopedic surgeries, such as tumor surgeries, infected wound debridements, and open fractures, where there is a high risk of surgical site infections (SSIs) caused by antibiotic-resistant bacteria. The study explores whether adding vancomycin and gentamicin to standard prophylaxis can better prevent infections, especially in cases involving resistant pathogens or ongoing antibiotic treatments. This phase 3 trial focuses on improving infection control in these high-risk surgical situations. Participants in the trial are randomly assigned to receive either standard antibiotic prophylaxis, which includes one to three doses of cefuroxime or alternatives like vancomycin or clindamycin in case of allergies, or an additional single-shot broad-spectrum prophylaxis with vancomycin and gentamicin given intravenously before surgery. The study allows for continued therapeutic antibiotic use if applicable and includes various surgical conditions such as tumor surgery, spine surgery with specific risk factors, and contaminated wounds. Each surgery is treated as a separate event, and patients undergoing multiple surgeries may receive different prophylaxis each time. During the study, participants will have daily visits starting with enrollment on Day 1, followed by an end-of-treatment visit around Day 14, and a test-of-cure surgical control visit around Day 42. A telephone follow-up occurs after one year for implant-related surgeries. Researchers will monitor surgical site infections at 6 weeks or 1 year depending on implant use, track antibiotic-resistant pathogens, assess changes in antibiotic therapies, record adverse events, and evaluate infection rates and bacterial colonization. The study aims to provide detailed insights into infection prevention and antimicrobial resistance in orthopedic surgery.
CONDITIONS
Brief Title
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Surgery performed under current or recent therapeutic antibiotics (antibiotic-free window less than 14 days and past antibiotic prescription longer than 4 days)
- Surgery for open fractures and wounds, including second and third look surgeries
- Revision of potentially contaminated wounds in the operating theatre
- Tumor surgery with prior radiotherapy and/or bone involvement
- Spine surgery with ASA score of 3 or higher, sacral involvement, or revision surgery
- Known skin colonization with multidrug-resistant Gram-negative bacteria
You will not qualify if you...
- Inability to understand the study procedure due to language or cognitive reasons
- Surgery without intraoperative microbiological samples
- Allergy or major intolerance to vancomycin or gentamicin
- Expected clinical follow-up less than 6 weeks after inclusion
- Pregnant or breastfeeding women
- Known carriage of multidrug-resistant Gram-negative bacteria in urine or anal region
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day 1 (surgery day)
Participants receive perioperative antibiotic prophylaxis with either standard antibiotic doses or an additional broad-spectrum single-shot regimen during their orthopedic surgery.
1 enrollment visit (in-person) on Day 1 and daily study visits during hospital stay
Follow-up
Duration - Up to 1 year post-surgery
Participants attend follow-up visits to assess surgical site infections and other outcomes, including clinical surgical control and telephone follow-up for implant-related surgeries.
1 end-of-treatment visit around Day 14, 1 test-of-cure visit around Day 42, and 1 telephone follow-up at 1 year (implant-related surgeries only)
Trial Site Locations
Total: 1 location
1
Balgrist University Hospital
Zurich, Switzerland, 8008
Actively Recruiting
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Research Team
I
Ilker Uçkay, Professor
M
Mazda Farshad, Professor
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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Published Research Related To This Trial
Changing perioperative prophylaxis during antibiotic therapy and iterative debridement for orthopedic infections?
Lydia Wuarin, Mohamed Abbas, Stephan Harbarth...
https://pubmed.ncbi.nlm.nih.gov/31851708Which Orthopaedic Patients Are Infected with Gram-negative Non-fermenting Rods?
Omid Jamei, Shpresa Gjoni, Besa Zenelaj...
https://pubmed.ncbi.nlm.nih.gov/28529866Antimicrobial Prophylaxis for the Prevention of Surgical Site Infections in Orthopaedic Oncology - A Narrative Review of Current Concepts.
Daniel Müller, Dominik Kaiser, Kati Sairanen...
https://pubmed.ncbi.nlm.nih.gov/31966954Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery-the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials.
Ilker Uçkay, Hagen Bomberg, Markus Risch...
https://pubmed.ncbi.nlm.nih.gov/38243311