Using broad-spectrum antibiotics to prevent infections in orthopedic surgery
Official title: Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials
Run by Balgrist University Hospital · NCT05502380 · Data updated 2026-11-12
This study tests whether using a stronger type of antibiotics before orthopedic surgery can help prevent infections in patients who are at high risk.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 1 site (Zurich) |
| Status | Recruiting |
| Started | September 15, 2022 |
| Main results expected | December 12, 2024 |
| Study ends | December 12, 2025 |
| Registry record updated | December 2, 2024 |
| Trial ID | NCT05502380 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older undergoing high-risk orthopedic surgeries, particularly those with open fractures, tumors, or known skin colonization with multidrug-resistant bacteria.
✕Probably not a fit
Patients who are not undergoing surgery with a high risk of infection or those with allergies to the antibiotics used in the study may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of broad-spectrum antibiotic prophylaxis in preventing surgical site infections (SSIs) in high-risk orthopedic surgery patients. It focuses on patients undergoing procedures with a high likelihood of antibiotic-resistant infections, such as those with open fractures or tumors. The study will compare standard antibiotic prophylaxis with a more comprehensive approach to address the risk of newly introduced pathogens during surgery. Participants will be monitored for infection rates and microbial colonization post-surgery.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of antibiotic-resistant surgical site infections in orthopedic patients.
How similar studies have gone: Previous studies have shown that tailored antibiotic prophylaxis can reduce infection rates, suggesting potential success for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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 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 Exclusion Criteria: * 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's running
-
Balgrist University Hospital
Zurich, Switzerland Recruiting
Study contacts
- Principal investigator: Ilker Uçkay, Professor — Balgrist University Hospital
- Study coordinator: Ilker Uçkay, Professor
- Email: ilker.uckay@balgrist.ch
- Phone: ++41 44 386 37 05
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.