Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05502380

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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