← Back to Clinical Trials
Recruiting Phase 3 NCT05502380

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

Condition Surgical Site Infection
Sponsor Balgrist University Hospital
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-15
Completion 2024-12-12
Interventions
Standard antibiotic prophylaxis

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief Summary

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

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

Related Trials

ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology
}