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Search / Trial NCT05502380

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

Launched by BALGRIST UNIVERSITY HOSPITAL · Aug 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Perioperative Antibiotic Prophylaxis Selection High Risk Patients Ranndomized Controlled Trial

ClinConnect Summary

This clinical trial is studying the use of broad-spectrum antibiotics to prevent infections in patients undergoing certain types of orthopedic surgeries, especially those at higher risk for antibiotic-resistant infections. The goal is to see if using these antibiotics in specific situations can help reduce the chances of infections that can occur after surgery. This is particularly important for patients who might be having surgery on open fractures, tumor-related surgeries, or surgeries involving the spine.

To participate in this trial, individuals must be at least 18 years old and scheduled for surgery while currently on or recently off antibiotics. They should also have certain conditions, such as open fractures or known skin colonization with resistant bacteria. Participants will receive careful monitoring and follow-up after their surgery, with a focus on understanding how the antibiotic treatment affects their recovery and any potential infections. It's important to note that some patients, such as those with specific allergies to certain antibiotics or those who are pregnant or breastfeeding, will not be eligible for this study.

Gender

ALL

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

About Balgrist University Hospital

Balgrist University Hospital is a leading academic medical center based in Zurich, Switzerland, renowned for its expertise in musculoskeletal health and rehabilitation. As a prominent sponsor of clinical trials, the hospital is dedicated to advancing medical research and improving patient outcomes through innovative studies in orthopedics, neurology, and rehabilitation sciences. With a strong commitment to interdisciplinary collaboration and patient-centered care, Balgrist University Hospital leverages its state-of-the-art facilities and a team of experienced researchers to drive clinical advancements and foster the translation of scientific discoveries into practical therapies.

Locations

Zurich, , Switzerland

Patients applied

0 patients applied

Trial Officials

Ilker Uçkay, Professor

Principal Investigator

Balgrist University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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