Overview

Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery

Status:
Not yet recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Balgrist University Hospital
Treatments:
Anti-Bacterial Agents
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